Phase 2
N=247
A Study for Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00804986 ↗Enrolled (actual)
247
Serious AEs
2.9%
Results posted
Jun 2011
Primary outcome: Primary: Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint — -0.60; -0.80; -1.24; -1.41 percentage of glycosylated hemoglobin — p=0.0109
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2428757 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint |
-0.60; -0.80; -1.24; -1.41; -1.37; -0.13 | 0.0109 sig |
| SECONDARY Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint |
-2.28; -0.85; -3.76; -0.92; -1.37; -4.22 | 0.655 |
| SECONDARY Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study |
1; 2; 1; 3; 2; 1 | — |
| SECONDARY Total Average Concentration (Cavg) of LY2428757 |
29.5; 118; 453; 877; 1290; 0 | — |
| SECONDARY Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint |
-2.14; -17.08; -30.13; -28.05; -32.85; 2.39 | 0.4848 |
| SECONDARY Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint |
-1370.49; -1709.67; -5786.59; -6354.83; -8025.33; -238.64 | 0.4193 |
| SECONDARY Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint |
3111.25; 3984.37; 12521.89; 14179.28; 8778.23; 3540.52 | — |
| SECONDARY Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint |
-683.72; 31434.85; 49370.53; 46280.14; 22012.58; 8714.30 | — |
| SECONDARY Change in Fasting Lipids From Baseline to Week 12 Endpoint |
-0.15; 0.08; -0.35; -0.31; -0.31; -0.22 | 0.693 |
| SECONDARY Change in Fasting Weight From Baseline to Week 12 Endpoint |
-0.75; -0.85; -2.12; -1.03; -2.60; -0.59 | 0.8003 |
| SECONDARY Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint |
0.2; -0.1; 0.3; 0.2; 0.1; 0.2 | — |
| SECONDARY Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint |
-0.3; -0.1; -0.9; -0.4; -0.3; -0.7 | — |
| SECONDARY Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint |
6.9; 6.2; 6.0; 6.0; 7.1; 2.7 | — |
| SECONDARY Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint |
88.9; 73.8; 76.2; 84.6; 81.0; 75.0 | — |
Summary
A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis that LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.
Eligibility Criteria
Inclusion Criteria
- Have type 2 diabetes mellitus for at least 6 months prior to entering the trial.
- Treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening.
- Have a glycosylated fraction of hemoglobin A (HbA1c) value of 7.0% - 10.0% at screening
- Women of child-bearing potential must test negative for pregnancy at screening and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study.
- Have a body mass index (BMI) between 25 and 40 kilograms per square meters kg/m^2) at screening
- Stable weight during the 3 months prior to screening.
Exclusion Criteria
- Use any antidiabetic agent other than metformin during the 2 months prior to screening.
- Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone bariatric surgery.
- Are currently taking prescription or over-the counter medications to promote weight loss.
- Have been previously diagnosed with pancreatitis
- Women who are breastfeeding.
- Have a history of myocardial infarction, unstable angina, coronary artery bypass graft (CABG), percutaneous coronary intervention, transient ischemic attack, stroke or decompensated congestive heart failure in the past 6 months.
- Have poorly controlled hypertension
Data sourced from ClinicalTrials.gov (NCT00804986). 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.