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Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes
This study is currently recruiting participants.
Verified by Eli Lilly and Company, January 2009
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00791479
  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 II

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions

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 ]

Estimated Enrollment: 225
Study Start Date: December 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
0.1 mg LY2189265 subcutaneous(SC) once weekly (QW)
Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
2: Experimental
0.5 mg LY2189265 SC QW
Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
3: Experimental
1.0 mg LY2189265 SC QW
Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
4: Experimental
3.0 mg LY2189265 SC QW
Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
5: Placebo Comparator
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 0.1-3 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, 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 = >6.0% to ≤ 8.5%) and at time of randomization for all patients = ≥7.0% 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791479

Contacts
Contact: There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 44 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

Responsible Party: Eli Lilly and Company ( Chief Medical Officer )
Study ID Numbers: 12565, H9X-MC-GBCK
Study First Received: November 12, 2008
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00791479  
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 and Social Development of the Russian Federation;   Spain: Ministry of Health

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

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009