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
Overview
- Phase
- Phase 2
- Intervention
- Metformin
- Conditions
- Diabetes
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Change in HbA1c
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Treatment Period: Placebo QD
Participants will receive daily SC placebo injections during the 12-week, double-blind treatment period.
Intervention: Metformin
Treatment Period: Placebo QD
Participants will receive daily SC placebo injections during the 12-week, double-blind treatment period.
Intervention: Placebo
Treatment Period: NNC0090-2746 QD
Participants will receive daily 1.8-mg SC injections of NNC0090-2746 during the 12-week, double-blind treatment period.
Intervention: Metformin
Treatment Period: NNC0090-2746 QD
Participants will receive daily 1.8-mg SC injections of NNC0090-2746 during the 12-week, double-blind treatment period.
Intervention: NNC0090-2746
Treatment Period: Liraglutide QD
Participants will receive open-label liraglutide via SC injection during the 12-week treatment period. The dose scheme will be as follows: 0.6 milligrams (mg) each day during Week 1, followed by 1.2 mg each day during Week 2, and 1.8 mg each day from Weeks 3 to 12.
Intervention: Liraglutide
Treatment Period: Liraglutide QD
Participants will receive open-label liraglutide via SC injection during the 12-week treatment period. The dose scheme will be as follows: 0.6 milligrams (mg) each day during Week 1, followed by 1.2 mg each day during Week 2, and 1.8 mg each day from Weeks 3 to 12.
Intervention: Metformin
Outcomes
Primary Outcomes
Change in HbA1c
Time Frame: Day 1; Week 8
Secondary Outcomes
- Change in body weight(Day 1; Week 8; Week 12)
- Percent change in body weight(Day 1; Week 8; Week 12)
- Change in fasting plasma glucose (FPG)(Day 1; Week 12)
- Change in post-prandial plasma glucose level(Day -7; Week 12)
- Change in post-prandial insulin level(Day -7; Week 12)
- Change in post-prandial C-peptide level(Day -7; Week 12)
- Change in beta-cell function(Day 1; Week 12)
- Incidence of treatment-emergent adverse events(Day 1; Week 18)
- Change in percent HbA1c(Day 1; Week 12)