A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870194
• Other study ID #: H8O-CR-GWDK
• Status: Completed
• Phase: Phase 4
• First received: March 25, 2009
• Last updated: March 20, 2015
• Start date: March 2009
• Est. completion date: April 2010

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of HealthAustralia: National Health and Medical Research CouncilGermany: Federal Institute for Drugs and Medical DevicesGreece: Ministry of Health and WelfareIndia: Drugs Controller General of IndiaSouth Korea: Korea Food and Drug Administration (KFDA)Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Present with type 2 diabetes

• Patients have been treated with a stable dose of the following for at least 3 months prior to screening:

• 100 mg/day sitagliptin and

• =1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).

• Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.

• Have a body mass index (BMI) =20 kg/m2 and <45 kg/m2

Exclusion Criteria:

• Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

• Have previously completed or withdrawn from this study or any other study investigating exenatide.

• Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.

• Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.

• Are currently treated with any of the following excluded medications:

• Thiazolidinediones (TZD) within 3 months of screening.

• Sulfonylurea (SU) within 3 months of screening.

• Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3 months of screening.

• Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.

• Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.

• Exogenous insulin within the 3 months prior to screening.

• Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.

• Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.

• Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide and sitagliptin
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day
• exenatide and placebo
exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Morón
Australia	Research Site	Adelaide
Australia	Research Site	Geelong
Australia	Research Site	Melbourne
Germany	Research Site	Aschaffenburg
Germany	Research Site	Asslar
Germany	Research Site	Beckum-Neubeckum
Germany	Research Site	Berlin
Germany	Research Site	Bosenheim
Germany	Research Site	Essen
Germany	Research Site	Falkensee
Germany	Research Site	Furth im Wald
Germany	Research Site	Grevenbroich
Germany	Research Site	Hamburg-Othmarschen
Germany	Research Site	Hohenmolsen
Germany	Research Site	Leipzig
Germany	Research Site	Neuwied
Germany	Research Site	Pohlheim
Germany	Research Site	Speyer
Greece	Research Site	Athens
Greece	Research Site	Thessaloniki
India	Research Site	Ahmedabad
India	Research Site	Bangalore
India	Research Site	Coimbatore
India	Research Site	Indore
India	Research Site	Jaipur
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Ulsan
Mexico	Research Site	Coatzacoalcos
Mexico	Research Site	Guadalajara
Mexico	Research Site	Merida
Mexico	Research Site	Monterrey
Mexico	Research Site	Tampico

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

Argentina,  Australia,  Germany,  Greece,  India,  Korea, Republic of,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (Percent)	Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]	Baseline to 20 Weeks	No
Secondary	Percentage of Patients Achieving HbA1c <=7.0%	Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)	Baseline to 20 Weeks	No
Secondary	Percentage of Patients Achieving HbA1c <7.0%	Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20)	Baseline to 20 Weeks	No
Secondary	Percentage of Patients Achieving HbA1c <=6.5%	Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)	Baseline to 20 Weeks	No
Secondary	Change in FSG (mmol/L)	Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)	Baseline to 20 Weeks	No
Secondary	Change in Body Weight (kg)	Change in body weight from baseline to endpoint (Week 20)	Baseline to 20 Weeks	No
Secondary	Change in Waist Circumference (cm)	Change in waist circumference from baseline to endpoint (Week 20)	Baseline to 20 Weeks	No
Secondary	Waist-to-Hip Ratio	Change in waist-to-hip ratio from baseline to endpoint (Week20)	Baseline to 20 Weeks	No
Secondary	SMBG (mmol/L)	7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)	Baseline to 20 Weeks	No
Secondary	Change in Triglycerides (mmol/L)	Change in triglycerides from baseline to endpoint (Week 20)	Baseline to 20 Weeks	No
Secondary	Change in HDL (mmol/L)	Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)	Baseline to 20 Weeks	No
Secondary	Change in LDL (mmol/L)	Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)	Baseline to 20 Weeks	No
Secondary	Change in Total Cholesterol (mmol/L)	Change in total cholesterol from baseline to endpoint (Week 20)	Baseline to 20 Weeks	No
Secondary	Incidence of Hypoglycemia (Overall)	Incidence of hypoglycemic episodes experienced overall during the study	Baseline to 20 Weeks	No
Secondary	Incidence of Severe Hypoglycemia(Overall)	Incidence of severe hypoglycemia experienced overall during the study	Baseline to 20 Weeks	No
Secondary	Incidence of Nocturnal Hypoglycemia (Overall)	Incidence of nocturnal hypoglycemia experienced overall during the study	Baseline to 20 Weeks	No
Secondary	Incidence of Confirmed Hypoglycemia(Overall)	Incidence of confirmed hypoglycemia experienced overall during the study	Baseline to 20 Weeks	No