A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

Diabetes Clinical Trial

Official title:

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase 2a Study With an Open-Label Active Group to Assess the Efficacy and Safety of Once-Daily NNC0090-2746 in Type 2 Diabetic Patients Inadequately Controlled With Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205528
• Other study ID #: NN9709-4336
• Secondary ID: U1111-1189-5627
• Status: Completed
• Phase: Phase 2
• Start date: August 18, 2014
• Est. completion date: September 15, 2015

Study information

• Verified date: July 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the efficacy, safety, and tolerability of once-daily subcutaneous (SC) injections of NNC0090-2746 for 12 weeks, as an adjunct to metformin, in participants with T2D.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 15, 2015
• Est. primary completion date: September 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participants aged 18 to 70 years, inclusive

• Active diagnosis of T2D for greater than or equal to (>/=) 3 months

• For females of childbearing potential and males with female partners of childbearing potential, agreement to use highly effective contraceptive measures

• Treated with a stable dose of metformin for at least 8 weeks prior to randomization, and expected to remain at the same stable dose throughout study participation

• Hemoglobin A1c (HbA1c) >/= 7.2% and less than or equal to (</=) 10.5%

• Fasting plasma glucose (FPG) less than (<) 250 milligrams per deciliter (mg/dL)

• C-peptide greater than (>) 1.5 nanograms per milliliter (ng/mL)

• Body mass index (BMI) >/= 27 kilograms per meter-squared (kg/m^2) and </= 44 kg/m^2

• Stable weight (+/- 5%) within 12 weeks prior to Screening

• Willing and able to maintain existing diet and exercise habits throughout the study

• Capable of performing SC self-injections on a daily basis during the study

Exclusion Criteria:

• Females who are pregnant or lactating

• History of type 1 diabetes (T1D), diabetes resulting from pancreatic injury, or secondary forms of diabetes such as Cushing's Syndrome or acromegaly

• History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia

• History of clinically significant diabetic complications such as diabetic proliferative retinopathy or severe diabetic neuropathy (requiring treatment with antidepressants or opioids)

• History of severe hypoglycemia within 6 months prior to Screening

• History of chronic gastrointestinal (GI) conditions that could impede gastric emptying or potentially affect the interpretation of the study data

• History of weight loss surgery or weight loss procedure involving the GI tract, such as gastric bypass, gastric stapling, or gastric banding

• History of an eating disorder (e.g., bulimia, anorexia)

• History of malignancy (except treated basal or squamous cell skin cancer) within 5 years prior to Screening

• Personal or family history of medullary thyroid carcinoma

• History of multiple endocrine neoplasia syndrome type 2

• History of chronic or acute pancreatitis or hemochromatosis

• History of significant cardiovascular disease (such as congestive heart failure New York Heart Association Class II to IV, myocardial infarction within the previous 6 months, coronary disease, or uncontrolled hypertension)

• History of clinically significant renal or liver disease

• History of hypersensitivity or previous intolerance to incretin or glucagon analogues

• Elevations in lipase or amylase levels at Screening > 1.5 times the upper limit of normal (ULN) and considered clinically significant by the investigator

• Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG), or hepatitis C antibody test at Screening

• Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to Screening, or active enrollment in another investigational medication or device study

• Any condition, disorder, or abnormal laboratory test findings at screening that, in the judgment of the investigator, would interfere with the participant's ability to comply with all study requirements, or would require the administration of a treatment during the study that could potentially affect the interpretation of the study data, or would place the participant at unacceptable risk by his/her participation in the study

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Liraglutide
Liraglutide will be self-administered daily via SC injection according to manufacturer specifications.
• Metformin
Metformin hydrochloride immediate- or extended-release oral tablets will be supplied by the participant or investigational site as standard-of-care treatment beginning at least 8 weeks prior to randomization and throughout the 12-week treatment period. Metformin will also be continued during the 4-week follow-up. Dose selection will be based upon manufacturer specifications.
• Placebo
Matching placebo to NNC0090-2746 will be self-administered daily via SC injection.
• NNC0090-2746
NNC0090-2746 solution will be self-administered in daily doses of 1.8 mg via SC injection.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Albuquerque	New Mexico
United States	Novo Nordisk Investigational Site	Berlin	New Jersey
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Chino	California
United States	Novo Nordisk Investigational Site	Cincinnati	Ohio
United States	Novo Nordisk Investigational Site	Corpus Christi	Texas
United States	Novo Nordisk Investigational Site	Eugene	Oregon
United States	Novo Nordisk Investigational Site	Evanston	Illinois
United States	Novo Nordisk Investigational Site	Greensboro	North Carolina
United States	Novo Nordisk Investigational Site	Hawaiian Gardens	California
United States	Novo Nordisk Investigational Site	Hialeah	Florida
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Knoxville	Tennessee
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	Manassas	Virginia
United States	Novo Nordisk Investigational Site	Oxon Hill	Maryland
United States	Novo Nordisk Investigational Site	Port Orange	Florida
United States	Novo Nordisk Investigational Site	Sanford	Florida
United States	Novo Nordisk Investigational Site	Spring Valley	California
United States	Novo Nordisk Investigational Site	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

Frias JP, Bastyr EJ 3rd, Vignati L, Tschöp MH, Schmitt C, Owen K, Christensen RH, DiMarchi RD. The Sustained Effects of a Dual GIP/GLP-1 Receptor Agonist, NNC0090-2746, in Patients with Type 2 Diabetes. Cell Metab. 2017 Aug 1;26(2):343-352.e2. doi: 10.101 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		Day 1; Week 8
Secondary	Change in body weight		Day 1; Week 8; Week 12
Secondary	Percent change in body weight		Day 1; Week 8; Week 12
Secondary	Change in fasting plasma glucose (FPG)		Day 1; Week 12
Secondary	Change in post-prandial plasma glucose level		Day -7; Week 12
Secondary	Change in post-prandial insulin level		Day -7; Week 12
Secondary	Change in post-prandial C-peptide level		Day -7; Week 12
Secondary	Change in beta-cell function	According to the Homeostasis Model Assessment (HOMA) score	Day 1; Week 12
Secondary	Incidence of treatment-emergent adverse events		Day 1; Week 18
Secondary	Change in percent HbA1c		Day 1; Week 12