Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus.
Full description
Participants in the trial will be randomized to one of the LY2189265 doses (4 doses are planned, range 0.1-1.5 milligram [mg]) or placebo. The main purpose is to assess dose-dependent effect of this new compound on blood glucose over a period of 12 weeks. Therefore, glycosylated hemoglobin (HbA1c) is chosen as the primary efficacy measure. Several other attributes of glycemic control and endocrine function of pancreas will be assessed as secondary objectives. These secondary objectives will be used to compare the effect of the experimental compound and placebo. Since LY2189265 is in early phase of development, comprehensive safety assessment is planned to learn more about possible side-effects and to establish benefit/risk profile of individual doses of the drug. The trial is organized in four phases: screening, lead-in period to establish baseline status of participants in each group, treatment period during which participants will be randomized into 1 of 5 groups (4 will receive one of the LY2189265 doses, 1 group will receive placebo), and safety follow up. Maximum of 9 study visits are planned. Study drug (LY2189265 or placebo) will be administered once weekly via subcutaneous (SC) injections. Rescue intervention was allowed after randomization for those participants whose hyperglycemia reached pre-defined unacceptable high values. Participants on rescue therapy remained in the study and continued to receive study drug. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses.
A 3-mg LY2189265 dose was discontinued and replaced with the 1.5 mg dose based on dose finding Study H9X-MC-GBCF; NCT00734474. Except where noted, data summaries from the 3 discontinued 3-mg LY2189265 participants (n=3) are not included due to the small number of participants and the short treatment duration.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diabetes mellitus, type 2
- Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
- Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
- Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin monotherapy >6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to ≤9.5%
- Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
- Have a body mass index (BMI) between 23 and 40 kilograms/meter squared (kg/m^2), inclusive, for participants who are native to, and reside in, South and/or East Asia; all other participants must have a BMI between 25 and 40 kg/m^2, inclusive.
- Stable weight for 3 months prior to screening
Exclusion criteria
- Diabetes mellitus, type 1
- Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
- Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
- Use of medications (prescription or over-the counter) to promote weight loss
- Chronic (>2 weeks) use of systemic glucocorticoid therapy
- Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
- Use of central nervous system (CNS) stimulant (for example, Ritalin-sustained release [SR])
- Cardiovascular event within 6 months prior to screening
- Poorly controlled hypertension (determined by a mean seated systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or mean seated diastolic BP ≥95 mmHg at screening or randomization)
- Electrocardiogram (ECG) reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease
- Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels >3.0 times upper limit of normal
- Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis at time of screening
- Amylase ≥3 times the upper limit of normal and/or lipase ≥2 times upper limit of normal which are determined by central labs at the time of screening
- Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) for men or ≥1.4 mg/dL for women or a creatinine clearance <60 milliliter (mL)/minute which are determined by central labs at the time of screening
- Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring hospitalization in the 6 months prior to screening)
- Significant active, uncontrolled endocrine or autoimmune abnormality
- History of a transplanted organ (corneal transplants are allowed)
- Active or untreated malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
- Have any other condition, in the opinion of the investigator, that may preclude the participant from following or completing the protocol
- Investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted)
- Sponsor employees
- Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study
- Have previously completed or withdrawn from this study after providing informed consent
Trial design
Primary purpose
Allocation
Interventional model
Masking
167 participants in 5 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal