Phase 2
Completed N=262
A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00630825 ↗Enrolled (actual)
262
Serious AEs
2.7%
Results posted
Dec 2014
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus — -1.52; -1.29; -1.28; -0.27 percentage of glycosylated hemoglobin — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus |
-1.52; -1.29; -1.28; -0.27 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
-2.64; -2.04; -2.09; -0.49 | <0.001 sig |
| SECONDARY Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal) |
11.03; 11.12; 10.32; 10.76; 8.16; 9.92 | <0.001 sig |
| SECONDARY Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles |
-31.19; -35.94; -31.66; -8.10; -43.00; -40.68 | <0.001 sig |
| SECONDARY Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2) |
45.61; 44.26; 39.20; 1.04; 3.58; -1.65 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5% |
3.1; 4.6; 1.5; 4.5; 0.0; 1.5 | — |
| SECONDARY Change From Baseline in Body Weight |
-1.28; -1.08; -0.50; -0.06; -2.12; -1.67 | <0.001 sig |
| SECONDARY Change From Baseline in Waist Circumference |
-1.92; -1.51; -1.33; 0.20 | 0.009 sig |
| SECONDARY Nausea and Dyspepsia Measured by Visual Analog Scale |
4.81; 3.56; 3.70; 3.35; 5.07; 3.85 | — |
| SECONDARY Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores |
0.55; 0.57; 0.62; 0.35; 0.46; 0.30 | — |
| SECONDARY Number of Participants With a Hypoglycemic Event |
17; 17; 17; 9; 11; 13 | — |
| SECONDARY Rate of Hypoglycemia Per 30 Days |
0.69; 0.80; 0.70; 0.24 | — |
| SECONDARY Change From Baseline in Lipids |
-0.34; -0.05; -0.09; 0.18; -0.26; -0.09 | — |
| SECONDARY Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire |
72.7; 87.0; 87.5; 89.1; 83.3; 90.2 | — |
| SECONDARY Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire |
— | — |
| SECONDARY Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC) |
14587; 7876; 4488 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00630825). 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.