NCT00630825CompletedPhase 2
The Effect of Dose Titration of LY2189265 in Overweight and Obese Patients With Type 2 Diabetes Mellitus
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 262
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Study Overview
Brief Summary
To study once weekly injections of LY2189265 compared to placebo on blood glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight Type 2 Diabetes Mellitus participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 Diabetes Mellitus >3 months by history prior to entering the trial, based on disease diagnostic criteria from the American Diabetes Association (ADA 2007).
- •Men or women 18 years of age or older. Women must have a negative pregnancy test and be willing to use birth control during study duration and one month post.
- •Have glycosylated hemoglobin (HbA1c) of >7.0% to ≤10.5% as determined by central laboratory at screening.
- •Have a body mass index (BMI) between 27 and 40 kilograms/meter squared (kg/m^2), inclusive.
- •Have been on the same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. Chlorpropamide or Diabinese, Glimepiride or Amaryl, Tolbutamide or Orinase, Tolazamide or Tolinase, Glipizide or Glucotrol, Glyburide also known as Micronase, Diabeta, or Glynase), biguanides (e.g. Glucophage or metformin), thiazolidinediones (e.g. Rosiglitazone or Avandia, or Pioglitazone or Actos), or dipeptidyl peptidase 4 (DPP-IV) inhibitors (e.g. Sitagliptin or Januvia). A combination pill of any 2 of these drugs is allowed (1 only), (e.g. Metformin and Glipizide or Metaglip), (e.g. Metformin and Glyburide or Glucovance), (e.g. Pioglitazone and Glimepiride or Duetact), or (e.g. Sitagliptin and Metformin or Janumet).
Exclusion Criteria
- •Have known Type 1 Diabetes Mellitus
- •Have taken glucagon-like peptide-1 (GLP-1) or any GLP-1 analog drug (Byetta)
- •Have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (percutaneous transluminal coronary angioplasty [PTCA], open heart surgery, or coronary artery bypass graft [CABG]), a transient ischemic attack (TIA) or stroke (cerebrovascular accident) in the last 6 months prior to screening.
- •Have acute or chronic hepatitis or elevated liver function tests (alanine transaminase), a history of chronic or recurrent pancreatitis. Have renal disease or a serum creatinine (blood test) >2 milligrams per deciliter (mg/dL). If taking biguanides (e.g. metformin or Glucophage), or DPP-IV inhibitors (e.g. Sitagliptin or Januvia or Janumet), creatinine must be ≤1.5 mg/dL.
- •Currently taking prescription or over the counter medications to prevent weight loss.
Arms & Interventions
1.0/2.0 milligram (mg) LY2189265
Experimental
LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
Intervention: LY2189265 (Drug)
1.0/1.0 milligram (mg) LY2189265
Experimental
LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks
Intervention: LY2189265 (Drug)
0.5/1.0 milligram (mg) LY2189265
Experimental
LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
Intervention: LY2189265 (Drug)
Placebo
Placebo Comparator
Placebo: subcutaneous (SC) injection, once weekly (QW) for 16 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Time Frame: Baseline, 16 weeks
Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).
Secondary Outcomes
- Change From Baseline in Fasting Blood Glucose(Baseline, 16 weeks)
- Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles(2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.)
- Change From Baseline in Waist Circumference(Baseline, 16 weeks)
- Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire(Baseline and 4 and 8 and 16 weeks)
- Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)(Baseline, 16 weeks)
- Change From Baseline in Body Weight(Baseline, 4, 8, and 16 weeks)
- Rate of Hypoglycemia Per 30 Days(Baseline through 16 weeks)
- Change From Baseline in Lipids(Baseline, 16 weeks)
- Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%(Baseline and 4 and 8 and 16 weeks)
- Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores(Baseline and 4 and 8 and 16 weeks)
- Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)(Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks)
- Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)(Baseline and 16 weeks)
- Nausea and Dyspepsia Measured by Visual Analog Scale(One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits)
- Number of Participants With a Hypoglycemic Event(Baseline through 4, 8, and 16 weeks)
- Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire(Baseline and 4 and 8 and 16 weeks)
Investigators
Study Sites (1)
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