Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00791479
First received: November 12, 2008
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on HbA1c at 12 weeks in patients with type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2189265 and Lifestyle Measures
Drug: Placebo solution and Lifestyle Measures
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • HbA1c change from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting blood glucose change from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  • Blood glucose values by 24-hour, 7-point self monitored blood glucose (SMBG) profiles [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Beta-cell function (HOMA2-B) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Insulin sensitivity and fasting insulin concentration (HOMA2-S) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who achieve HbA1c <7% or <6.5% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Rate and incidence of self-reported hypoglycemic events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Antibody production and effects to LY2189265 [ Time Frame: 4 weeks, 12 weeks ] [ Designated as safety issue: Yes ]
  • Collection and Evaluation of plasma levels (Pharmacokinetics - PK) of LY2189265 [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: Yes ]
  • Treatment Emergent Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Blood Pressure (BP) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Pulse rate (PR) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiograms (ECGs) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Body Weight [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 168
Study Start Date: December 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
0.1 mg LY2189265 subcutaneous(SC) once weekly (QW)
Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
Experimental: 2
0.5 mg LY2189265 SC QW
Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
Experimental: 3
1.0 mg LY2189265 SC QW
Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
Experimental: 4
1.5 mg LY2189265 SC QW
Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
Placebo Comparator: 5
Placebo solution injected SC QW
Drug: Placebo solution and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks

Detailed Description:

Patients in the trial will be randomized to one of the LY2189265 doses (4 doses are planned, range 0.1-1.5mg) 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, hemoglobin A1c 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 patients will be randomized into 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 SC injections.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 patients = ≥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 kg/m2, inclusive, for patients who are native to, and reside in, South and/or East Asia; all other patients must have a BMI between 25 and 40 kg/m2, 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 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 CNS stimulant (for example, Ritalin-SR)
  • Cardiovascular event within 6 months prior to screening
  • Poorly controlled hypertension (determined by a mean seated systolic BP ≥160 mm Hg or mean seated diastolic BP ≥95 mm Hg at screening or randomization)
  • 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 mg/dL for men or ≥1.4 mg/dL for women or a creatinine clearance <60 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 patient 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791479

  Show 46 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Chair: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00791479     History of Changes
Other Study ID Numbers: 12565, H9X-MC-GBCK, CTRI/2009/091/000105
Study First Received: November 12, 2008
Last Updated: October 25, 2010
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
Poland: Ministry of Health
Croatia: Ministry of Health and Social Care
India: Ministry of Health
Denmark: Danish Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Ministry of Health

Keywords provided by Eli Lilly and Company:
Diabetes, type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014