Study In People With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of Oral GW677954 as a Monotherapy for 12 Weeks Duration in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196989
• Other study ID #: ADG20001
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: March 21, 2017
• Start date: September 2005
• Est. completion date: April 2007

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects with T2DM (Type 2 Diabetes Mellitus).

Description:

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Study To Evaluate Efficacy, Safety And Tolerability Of Oral GW677954 Capsules (2.5, 5, 10, 15 And 20 Mg Once A Day) As A Monotherapy (Diet and/or exercise treated) Or As An Add-On To Metformin For 16 Weeks Duration In Subjects With Type 2 Diabetes Mellitus

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• Subjects with T2DM as defined by the criteria of the ADA and/or recognized by WHO Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2004], for at least 3 months preceding screening (see Section 15.3, Appendix 3:, "Diagnosis and Classification of Diabetes Mellitus").

• To be eligible for Randomization into the trial, a subject must satisfy all of the following glycemic criteria:

• HbA1c level via central laboratory at the pre-screening visit

• If HbA1c = 8.0% but = 10.0%: subject may proceed to Randomization;

• If HbA1c = 7.8% but < 8.0%, subject not eligible to proceed, but may be retested once to establish eligibility (or lack thereof). If HbA1c level = 8.0% upon retest, subject is eligible to proceed; otherwise they should be withdrawn.

• If HbA1c < 7.8%, subject not eligible to proceed (no retest allowed).

• FPG level via central laboratory at the pre-screening visit must be < 270 mg/dL (15.0 mmol/L). FPG may be retested within a week to confirm eligibility (or lack thereof).

• Concurrent T2DM therapy:

• Diet and/or exercise treated: Must not have taken antidiabetic medication for at least 2 months prior to the pre-screening visit, OR

• Metformin monotherapy: Subjects entering the study on metformin must be on the same dose, formulation and regimen of metformin for at least 2 months prior to the pre-screening visit, AND

• TZDs and insulin are excluded in the 3 months prior to the Screening visit for all subjects.

• Males and females who are 18 to 70 years of age inclusive at the time of Screening.

• If female, eligible to enter and participate in this study:

• If of non-childbearing potential (i.e., physiologically incapable of becoming pregnant (tubal ligation), including any female who is post-menopausal [>1 year without menstrual period]); or,

• If of child-bearing potential, has a negative pregnancy test at Screening (serum), at Randomization (urine) and:

• Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or

• Uses double-barrier methods of contraception; condoms with the use of caps (with spermicide) and IUDs are acceptable, or

• Uses hormonal contraceptives (oral, depots, patches etc) with double- barrier methods of contraception as outlined above, or

• Abstains from sexual intercourse, or

• Is with a same sex partner and does not participate in bisexual activities where there is any risk of pregnancy.

• Body Mass Index (BMI): =25 and =40 kg/m² and weigh at least 50 kg at Screening.

• If subject is a smoker, must be able to abstain while in clinic at each visit.

• Subject has given full written informed consent prior to any study related procedures are performed.

Exclusion criteria:

Exclusion Criteria:

• Metabolic Disease including:

• Diagnosis of Type 1 diabetes mellitus

• Uncorrected thyroid dysfunction. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 1 month prior to Screening, and who have a screening thyroid stimulating hormone (TSH) within the upper limit of normal may participate).

• Significant weight gain or loss (defined as > 5% of total body weight) within the 3 months prior to Screening.

• Previous use of insulin for treatment of hyperglycemia within 3 months of Screening.

• History of recent clinically significant cardiovascular disease including:

• History or ECG evidence of prior myocardial infarction within 6 months prior to Screening.

• Current unstable angina or history of unstable angina in past 6 months.

• Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery that is either planned or occurred in the 6 months prior to Screening.

• Clinically significant arrhythmia or valvular heart disease.

• Congestive heart failure (CHF) with New York Heart Association (NYHA) Class II-IV symptoms (see Section 15.4, Appendix 4).

• Blood pressure > 160/100 mmHg or resting heart rate > 100 bpm. Note: subjects using antihypertensives [e.g., beta blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers and diuretics] must be on stable doses during the 30 days prior to Screening and during the trial.

• Has a QTc interval (Bazett's) > 440 msec in males and > 450 msec in females at Screening.

• Clinically significant ECG abnormalities which, in the opinion of the Investigator, may affect the interpretation of safety data, or which otherwise, contraindicates participation in a clinical trial with a new chemical entity.

• History of chronic pancreatitis.

• Familial hypercholesterolemia.

• TGs =800 mg/dL (8.96 mmol/L) at Screening.

• Serum creatinine at screening > 1.4 mg/dL (124 µmol/L) for women, or > 1.5 mg/dL (133 µmol/L) for men.

• Clinically significant anemia defined by hemoglobin concentrations <12.0 g/dL or < 120.0 g/L for males and < 11.0 g/dL or < 110.0 g/L for females.

• History of significant co-morbid diseases (e.g., cholelithiasis, gastrointestinal disease, etc.) that would preclude participation in the study.

• Documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen and/or hepatitis C antibody) at Screening, and/or clinically significant hepatic enzyme elevation including:

•Any one of the following enzymes greater than 2.5 times the upper limit of normal (ULN) value at Screening:

• Alanine aminotransferase (ALT)

• Aspartate aminotransferase (AST)

• Alkaline phosphatase (ALP)

• Total or direct bilirubin > 1.5 times the ULN at Screening, unless consistent with presumed or diagnosed Gilbert's disease.

• History of metabolic acidosis, rhabdomyolysis, myalgia, myositis or myopathy after taking statins or fibrates.

• Any subject who has withdrawn therapy due to AEs after taking a PPAR? or a PPARa/? dual agonist, either marketed (e.g., troglitazone, rosiglitazone or pioglitazone) or under current or previous clinical investigation.

• Signs or symptoms of myositis at Screening (or upon 1 repeat test), and/or creatinine phosphokinase (CPK)=3.0 times ULN

• Is currently taking or has taken any of the following medications in the 3 months prior to the pre-screening visit:

• Anti-obesity agents (including fat absorption blocking agents)

• St. John's Wort

• Warfarin and other oral anticoagulants (excluding aspirin and non-steroidal anti-inflammatory drugs)

• Digoxin

• Oral or injectable corticosteroids (inhaled and intranasal steroids are acceptable)

• Use of antidiabetic agents (other than metformin) in the 2 months prior to the pre-screening visit.

• Use of TZDs in the 3 months prior to the pre-screening visit.

• Methotrexate, cyclosporine or monoclonal antibodies (e.g., alemtuzumab, gemtuzumab ozogamicin, rituximab, trastuzumab, ibritumomab, tiuxetan) for rheumatoid arthritis or psoriasis.

• Atypical antipsychotic medications [e.g., aripiprazole (Abilify), risperidone (Risperdal), clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), and ziprasidone (Geodon)].

• Antiretroviral drugs

• Use of lipid lowering agents within 3 months prior to the pre-screening visit. This includes statins, fibrates, ezetimibe (Zetia), niacin and bile acid sequestrants.

• Monoamine oxidase inhibitors

• History of cancer except for the following:

• Basal cell carcinoma or superficial squamous cell carcinoma treated by local excision.

• Cervical cancer in situ treated definitively more than 6 months prior to screening.

• Women who are lactating, pregnant, or planning to become pregnant.

• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to any drug chemically related to the study drug.

• Known allergy to any of the capsule excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician, contradicts participation. Hypersensitivity to metformin or any of its components (for subjects entering on metformin).

• Has a history of substance and/or alcohol abuse within the past year as determined by the Investigator at screening or during treatment:

• Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.

• History of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.

• Received treatment with a new molecular entity (investigational drug) during the previous 4 months or participated in any other trial during the previous 3 months, or has participated in a previous study with GW677954. A new molecular entity is defined as any compound not in Phase 3. (The washout is from last dose of investigational product in the previous study until the first dose of investigational product.)

• Likely to be non-compliant, in the investigator's opinion, with respect to the protocol and related scheduled visits.

• Subject has any concomitant medical condition which in the opinion of the investigator makes them unsuitable to participate in the study.

• Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Pioglitazone

• GW677954

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	San Juan
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Carina Heights	Queensland
Australia	GSK Investigational Site	Keswick	South Australia
Australia	GSK Investigational Site	Miranda	New South Wales
Australia	GSK Investigational Site	Port Lincoln	South Australia
Australia	GSK Investigational Site	Ringwood East	Victoria
Australia	GSK Investigational Site	Spring Hill	Queensland
Canada	GSK Investigational Site	Bonaventure	Quebec
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Granby	Quebec
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Langley	British Columbia
Canada	GSK Investigational Site	Laval	Quebec
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Longueuil	Quebec
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Saint John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Saint Marc Des Carrieres	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Smiths Falls	Ontario
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Thornhill	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Waterloo	Ontario
Canada	GSK Investigational Site	Winnipeg	Manitoba
Colombia	GSK Investigational Site	Bogotá
Costa Rica	GSK Investigational Site	San José
Czech Republic	GSK Investigational Site	Ceske Budejovice
Czech Republic	GSK Investigational Site	Cheb
Czech Republic	GSK Investigational Site	Olomouc
Czech Republic	GSK Investigational Site	Praha 10
Czech Republic	GSK Investigational Site	Praha 2
Czech Republic	GSK Investigational Site	Praha 5
Czech Republic	GSK Investigational Site	Praha 5
Ecuador	GSK Investigational Site	Quito
Latvia	GSK Investigational Site	Cesis
Latvia	GSK Investigational Site	Daugavpils
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Tukums
Mexico	GSK Investigational Site	Cuernavaca	Morelos
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Mexico, D.F.
Mexico	GSK Investigational Site	Monterrey	Nuevo León
Mexico	GSK Investigational Site	Pachuca	Hidalgo
Mexico	GSK Investigational Site	Tijuana	Baja California Norte
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Rotorua
New Zealand	GSK Investigational Site	Tauranga
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	San Isidro	Lima
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Perm
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	Tumen
Russian Federation	GSK Investigational Site	Ufa
Russian Federation	GSK Investigational Site	Yaroslavl
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Alhambra	California
United States	GSK Investigational Site	Artesia	California
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Chandler	Arizona
United States	GSK Investigational Site	Cite	Tennessee
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Duluth	Georgia
United States	GSK Investigational Site	East Providence	Rhode Island
United States	GSK Investigational Site	Edmonds	Washington
United States	GSK Investigational Site	Everett	Washington
United States	GSK Investigational Site	Franklin	Ohio
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Inglewood	California
United States	GSK Investigational Site	Irvine	California
United States	GSK Investigational Site	Kingsport	Tennessee
United States	GSK Investigational Site	LaJolla	California
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Monroe	Washington
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Northport	Alabama
United States	GSK Investigational Site	Northridge	California
United States	GSK Investigational Site	Norwalk	California
United States	GSK Investigational Site	Norwich	Connecticut
United States	GSK Investigational Site	Pahrump	Nevada
United States	GSK Investigational Site	Pasadena	California
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Santa Fe	New Mexico
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Simpsonville	South Carolina
United States	GSK Investigational Site	Springfield	Illinois
United States	GSK Investigational Site	St. Cloud	Florida
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Tustin	California
United States	GSK Investigational Site	Tyler	Texas
United States	GSK Investigational Site	Virginia Beach	Virginia
United States	GSK Investigational Site	Vista	California
United States	GSK Investigational Site	Wauwatosa	Wisconsin
United States	GSK Investigational Site	West Hills	California
United States	GSK Investigational Site	West Jordan	Utah
United States	GSK Investigational Site	West Yarmouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Colombia,  Costa Rica,  Czech Republic,  Ecuador,  Latvia,  Mexico,  New Zealand,  Peru,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from Baseline (Day 1) in glycated hemoglobin (HbA1c) levels at Week 16 as a measure of improvement in glucose control	Improvement in glucose control was measured by means of reduction in glycated hemoglobin (Hb) levels in blood.	Week (W) 16
Secondary	Percentage change from Baseline (Day 1) in fasting HbA1c levels at Weeks 4, 8 and 12	Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood. Change from Baseline is the value at indicated time point minus the value at Baseline.	Weeks 4, 8, and 12
Secondary	Change from Baseline (Day 1) in fasting plasma glucose (FPG) at Weeks 1, 2, 4, 6, 8, 12 and 16	Change from Baseline is the value at indicated time point minus the value at Baseline.	W1, W2, W4, W6, W8, W12, and W16
Secondary	Change from Baseline (Day 1) in fasting fructosamine at Weeks 2 and 4	Change from Baseline is the value at indicated time point minus the value at Baseline.	Baseline (Day 1), W2, W4
Secondary	Percentage of participants achieving target HbA1c levels at Weeks 4, 8, 12, and 16	Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood. The ideal concentration of HbA1c was desired to be less than or equal to 7%.	Weeks 4, 8, 12, and 16
Secondary	Percentage of participants achieving a decrease in HbA1c of >= 0.7% from Baseline (Day 1) at Weeks 4, 8, 12 and 16	Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood.	Baseline (Day 1), Weeks 4, 8, 12, and 16
Secondary	Percentage of participants achieving target range of FPG at Weeks 1, 2, 4, 6, 8, 12 and 16	The target range for FPG was <=126 milligrams per deciliter (mg/dL) or 7.0 millimoles per liter (mmol/L) to <=140 mg/dL or 7.8 mmol/L	Weeks 1,2, 4, 6, 8, 12, and 16
Secondary	Percentage of participants achieving a decrease from Baseline (Day 1) of >=30 mg/dL [1.66 mmol/L] in FPG at Weeks 1, 2, 4, 6, 8, 12 and 16	Change from Baseline is the value at indicated time point minus the value at Baseline.	Weeks 1, 2, 4, 6, 8, 12, and 16
Secondary	Ratio to the Baseline (percentage change) of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and free fatty acids (FFA) at Weeks 2, 4, 8, 12, and 16	This data analysis was based on log-transformed data.	Baseline (Day 1), Weeks 2, 4, 8, 12, and 16
Secondary	Percentage change from Baseline (Day 1) in non-HDL-C based on log-transformed data at Week 16	Change from Baseline is the value at indicated time point minus the value at Baseline.	At Week 16
Secondary	Percentage change from Baseline (Day 1) in very low density lipoprotein-cholesterol (VLDL-C), apolipoprotein AI (Apo AI), AII, and B at Week 16.	Change from Baseline is the value at indicated time point minus the value at Baseline.	At Week 16
Secondary	Change from Baseline (Day 1) in Apo B/TC, TC/HDL-C, and LDL-C/Apo B ratio at Week 16	Change from Baseline is the value at indicated time point minus the value at Baseline.	At Week 16
Secondary	Change from Baseline (Day 1) in hemoglobin at Week 16	This analysis was performed in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline.	At Week 16
Secondary	Change from Baseline (Day 1) in hematocrit at Week 16	Change from Baseline is the value at indicated time point minus the value at Baseline.	Wekk 16
Secondary	Change from Baseline (Day 1) in systolic and diastolic blood pressure (SBP and DBP) at Week 16	Systolic blood pressure )SBP) and diastolic blood pressure (DBP) were measured in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline.	At Week 16
Secondary	Change from Baseline (Day 1) in heart rate at Week 16	Heart rate was measured in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline.	Week 16
Secondary	Change from Baseline (Day 1) in body weight at Week 16	Change from Baseline is the value at indicated time point minus the value at Baseline.	Week 16
Secondary	Change from Baseline (Day 1) in 12 lead electrocardiogram (ECG) measures including PR interval, QT interval, QTc interval and QRS duration at Week 16	QT(c) interval calculations were done by Bazett's method (QTc[B]) as well as by Fridericia's correction (QTc[F]). Change from Baseline is the value at indicated time point minus the Baseline value.	Week 16
Secondary	Number of participants with clinical hematology, chemistry, urinalysis, exploratory cardiac parameters of potential clinical concern (PCC) along with serum pregnancy test over period	Participants were analyzed for any abnormality for laboratory parameters either higher or lower than the potential clinical concern range.	Upto 16 weeks
Secondary	Number of participants with hypoglycemic events as a measure of ophthalmic assessment	Participants received a glucose log for reading for routine recording of glucometer readings. Glucose values were recorded on timely basis.	Up to 16 weeks
Secondary	Number of participants with intensity of hypoglycemic events as a measure of ophthalmic assessment	Participants received a glucose log for reading for routine recording of glucometer readings. Glucose values were recorded on timely basis.	Up to 16 weeks
Secondary	Number of participants with adverse events (AEs) and serious adverse events (SAEs) over period	Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.	Up to 16 weeks
Secondary	Change from Baseline (Day 1) in phosphocreatine kinase (Creatine kinase-MB) over period	CK-MB is a cardiac biomarker.	Up to 16 weeks
Secondary	Number of participants with absolute Troponin-I (cTnI) levels over period	Troponin-I (cTnI) is a cardiac biomarker.	Up to 16 weeks
Secondary	Change from Baseline (Day 1) in fasting insulin at Week 8 and 16	Change from Baseline is the value at indicated time point minus the value at Baseline.	Week 8 and 16
Secondary	Change from Baseline (Day 1) in C-peptide at Week 8 and 16		Week 8 and 16
Secondary	Change from Baseline (Day 1) in HOMA-S at Week 16		Week 16
Secondary	Change from Baseline (Day 1) in QUICKI at Week 16		Week 16

External Links

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