A Study of LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin
Tracking InformationStart Date ICMJE | August 2008 |
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Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: August 12, 2008) | HbA1c change from baseline [ Time Frame: over 12 months ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00734474 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: August 12, 2008) | - Fasting blood glucose change from baseline [ Time Frame: over 6, 12, and 24 months ] [ Designated as safety issue: No ]
- Fasting insulin change from baseline [ Time Frame: over 12 and 24 months ] [ Designated as safety issue: No ]
- Body weight change from baseline [ Time Frame: over 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
- Waist circumference change from baseline [ Time Frame: over 12 and 24 months ] [ Designated as safety issue: Yes ]
- Proportion of patients who achieve an HbA1c <7% or < or = 6.5% [ Time Frame: over 12 and 24 months ] [ Designated as safety issue: No ]
- Incidence of hypoglycemic episodes [ Time Frame: over 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
- Beta cell function and insulin sensitivity (HOMA2) [ Time Frame: over 12 and 24 months ] [ Designated as safety issue: No ]
- Safety: laboratory tests, lipids parameter, TEAEs, vital signs, and ECG parameters [ Time Frame: over 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
- Patient-reported outcomes (IWQoL-Lite) [ Time Frame: over 12 and 24 months ] [ Designated as safety issue: No ]
- Patient-reported outcomes (EQ-5D) [ Time Frame: over 12 and 24 months ] [ Designated as safety issue: No ]
- Resource utilization [ Time Frame: over 12 and 24 months ] [ Designated as safety issue: No ]
- Pharmacokinetics of LY2189265 [ Time Frame: over 24 months ] [ Designated as safety issue: Yes ]
- Antibodies to LY2189265 [ Time Frame: over 24 months ] [ Designated as safety issue: Yes ]
- HbA1c change from baseline [ Time Frame: over 6 and 24 months ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | A Study of LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin |
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Official Title ICMJE | A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin |
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Brief Summary | This is an adaptive dose finding study and a phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to sitagliptin on glucose by measuring HbA1c change from baseline after twelve months in patients with type 2 diabetes mellitus on metformin. |
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Detailed Description | |
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Study Phase | Phase II, Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Diabetes Mellitus, Type 2 |
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Intervention ICMJE | - Drug: LY2189265
Subcutaneous injection once-weekly for up to 24 months - Drug: Sitagliptin 100mg, 24 months
One tablet by mouth daily for up to 24 months - Drug: Placebo solution
Subcutaneous injection once weekly for up to 24 months - Drug: Placebo tablet, 6 months
One tablet by mouth daily for up to 6 months - Drug: Placebo tablet, 24 months
One tablet by mouth daily for up to 24 months - Drug: Sitagliptin 100 mg, 18 months
One tablet by mouth daily for up to 18 months
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Study Arms / Comparison Groups | - 1: Experimental
0.25 mg LY2189265 Subcutaneous (SC) once weekly (QW) and placebo tablet 1 po qd Interventions: - Drug: LY2189265
- Drug: Placebo tablet, 24 months
- 2: Experimental
0.50 mg LY2189265 SC QW and placebo tablet 1 po qd Interventions: - Drug: LY2189265
- Drug: Placebo tablet, 24 months
- 3: Experimental
0.75 mg LY2189265 SC QW and placebo tablet 1 po qd Interventions: - Drug: LY2189265
- Drug: Placebo tablet, 24 months
- 4: Experimental
1.00 mg LY2189265 SC QW and placebo tablet 1 po qd Interventions: - Drug: LY2189265
- Drug: Placebo tablet, 24 months
- 5: Experimental
1.50 mg LY2189265 SC QW and placebo tablet 1 po qd Interventions: - Drug: LY2189265
- Drug: Placebo tablet, 24 months
- 6: Experimental
2.00 mg LY2189265 SC QW and placebo tablet 1 po qd Interventions: - Drug: LY2189265
- Drug: Placebo tablet, 24 months
- 7: Experimental
3.00 mg LY2189265 SC QW and placebo tablet 1 po qd Interventions: - Drug: LY2189265
- Drug: Placebo tablet, 24 months
- 8: Active Comparator
Sitagliptin 100 mg one tablet po qd and placebo solution injected SC QW Interventions: - Drug: Sitagliptin 100mg, 24 months
- Drug: Placebo solution
- 9: Placebo Comparator
Placebo tablet 1 po qd and placebo solution injected SC QW then after 6 months sitagliptin 100 mg one tablet po qd and placebo solution injected SC QW Interventions: - Drug: Placebo solution
- Drug: Placebo tablet, 6 months
- Drug: Sitagliptin 100 mg, 18 months
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Recruitment InformationEstimated Enrollment ICMJE | 1566 |
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Estimated Completion Date | August 2012 |
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Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: - Diabetes mellitus, type 2 for at least 6 months
- Treatment regimens: diet and exercise, metformin as monotherapy or in combination with another oral antihyperglycemic medication (OAM), or another OAM as monotherapy. Must be able to tolerate metformin at a dose of at least 1500 mg daily for 6 weeks prior to randomization.
- HbA1c value of ≥7.0% to ≤9.5%
- Body mass index (BMI) between 25 and 40 kg/m2, inclusive
- Stable weight for 3 months prior to screening
- Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
Exclusion Criteria: - Diabetes mellitus, type 1
- Use of a GLP-1 analog (for example, exenatide) within 6 months prior to screening or are being treated with insulin
- Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
- Use of medications to promote weight loss
- Cardiovascular event within 6 months prior to screening
- Poorly controlled hypertension
- ECG reading considered outside the normal limits or indicating cardiac disease
- Liver disease, hepatitis, chronic pancreatitis, idiopathic acute pancreatitis, or alanine transaminase (ALT) levels >3.0 times the upper limit of normal
- Serum creatinine ≥1.5 mg/dL or a creatinine clearance < 60 ml/minute
- Uncontrolled diabetes
- Uncontrolled endocrine or autoimmune abnormality
- History of a transplanted organ
- Chronic use of systemic glucocorticoid therapy
- Active or untreated malignancy
- Use of CNS stimulants
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Gender | Both |
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Ages | 18 Years to 75 Years |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY(1-877-285-4559) or | 1-317-615-4559 | | |
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Location Countries ICMJE | United States, Canada, France, Germany, India, Korea, Republic of, Mexico, Poland, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, United Kingdom |
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Administrative InformationNCT ID ICMJE | NCT00734474 |
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Responsible Party | Chief Medical Officer, Eli Lilly and Company |
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Study ID Numbers ICMJE | 11422, H9X-MC-GBCF, CTRI/2009/091/000969 |
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Study Sponsor ICMJE | Eli Lilly and Company |
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Collaborators ICMJE | - United BioSource Corporation
- Tessella Inc.
- Berry Consultants
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Investigators ICMJE | 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 | |
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Information Provided By | Eli Lilly and Company |
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