A Study for Patients With Type 2 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: LY2428757

Study type: Interventional

Funder types: Industry

Identifiers

NCT00804986

CTRI/2009/091/000091 (Registry Identifier)

I1I-MC-GECD (Other Identifier)

12134

Details and patient eligibility

About

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.

Enrollment: 247 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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247 participants in 6 patient groups, including a placebo group

0.5 mg LY2428757

Experimental group

Description:

Once weekly, subcutaneous injection of 0.5 milligram (mg) LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.

Treatment:

Drug: LY2428757

2.0 mg LY2428757

Experimental group

Description:

Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.

Treatment:

Drug: LY2428757

6.2 mg LY2428757

Experimental group

Description:

Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.

Treatment:

Drug: LY2428757

12.0 mg LY2428757

Experimental group

Description:

Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.

Treatment:

Drug: LY2428757

17.6 mg LY2428757

Experimental group

Description:

Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.

Treatment:

Drug: LY2428757

Placebo

Placebo Comparator group

Description:

Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.

Treatment:

Drug: Placebo