Phase 2
Completed N=420
A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes
Source: ClinicalTrials.gov NCT02119819 ↗Enrolled (actual)
420
Serious AEs
2.9%
Results posted
Apr 2021
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 — -1.07; -1.09; -1.44; -1.33 percentage of HbA1c — p=0.459
Summary
The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 |
-1.07; -1.09; -1.44; -1.33; -1.42; -0.29 | 0.459 |
| SECONDARY Change From Baseline in HbA1c at Week 24 |
-0.85; -1.14; -1.37; -1.29; -1.48; -0.38 | — |
| SECONDARY Percent Change From Baseline in Body Weight |
-1.09; -1.86; -2.01; -3.23; -2.04; -1.22 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
-20.881; -21.991; -31.309; -28.405; -39.074; -1.588 | — |
| SECONDARY Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values |
-26.8; -28.4; -34.3; -34.8; -38.7; -7.4 | — |
| SECONDARY Change From Baseline in Lipids |
1.56; 0.92; 0.90; 1.04; 2.35; 2.17 | — |
| SECONDARY Change From Baseline in Fasting Fibroblast Growth Factor 21 |
-0.07; 0.06; -0.03; -0.14; -0.09; -0.11 | — |
| SECONDARY Percentage of Participants Requiring Rescue Therapy |
6.1; 2.8; 2.7; 4.3; 2.9; 11.3 | — |
| SECONDARY Percentage of Participants Developing Anti-Drug Antibodies to LY2944876 |
1.7; 1.4; 1.5; 0; 1.6; 0 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876 |
607; 799; 1690; 2570 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876 |
88100; 117000; 247000; 381000 | — |
| SECONDARY Change From Baseline in Adiponectin Levels |
0.14; 0.03; -0.10; 0.12; 0.04; 0.03 | — |
| SECONDARY Change From Baseline in Beta-Hydroxy Butyrate Levels |
-0.27; -0.28; -0.13; -0.31; -0.29; -0.23 | — |
| SECONDARY Change From Baseline in Glucagon Levels |
-1.26; -2.65; -5.14; -6.21; -1.58; -0.04 | — |
| SECONDARY Change From Baseline in Insulin Levels |
0.30; 0.97; 0.03; 0.96; 2.78; -0.85 | — |
Eligibility Criteria
Inclusion Criteria
- Men or women with diabetes mellitus Type 2
- Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening
- Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening
Exclusion Criteria
- Women of child bearing potential
- Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months
- Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year
- Participants with impaired renal function (serum creatinine >124 micromole per liter (µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in men)
Data sourced from ClinicalTrials.gov (NCT02119819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.