A Study of LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin

This study has been completed.
Sponsor:
Collaborators:
United BioSource Corporation
Tessella Inc.
Berry Consultants
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00734474
First received: August 12, 2008
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2189265
Drug: Sitagliptin 100mg, 24 months
Drug: Placebo solution
Drug: Placebo tablet, 6 months
Drug: Placebo tablet, 24 months
Drug: Sitagliptin 100 mg, 18 months
Phase 2
Phase 3

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: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1566
Study Start Date: August 2008
Study Completion Date: July 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
0.25 mg LY2189265 Subcutaneous (SC) once weekly (QW) and placebo tablet 1 po qd
Drug: LY2189265
Subcutaneous injection once-weekly for up to 24 months
Other Name: Dulaglutide
Drug: Placebo tablet, 24 months
One tablet by mouth daily for up to 24 months
Experimental: 2
0.50 mg LY2189265 SC QW and placebo tablet 1 po qd
Drug: LY2189265
Subcutaneous injection once-weekly for up to 24 months
Other Name: Dulaglutide
Drug: Placebo tablet, 24 months
One tablet by mouth daily for up to 24 months
Experimental: 3
0.75 mg LY2189265 SC QW and placebo tablet 1 po qd
Drug: LY2189265
Subcutaneous injection once-weekly for up to 24 months
Other Name: Dulaglutide
Drug: Placebo tablet, 24 months
One tablet by mouth daily for up to 24 months
Experimental: 4
1.00 mg LY2189265 SC QW and placebo tablet 1 po qd
Drug: LY2189265
Subcutaneous injection once-weekly for up to 24 months
Other Name: Dulaglutide
Drug: Placebo tablet, 24 months
One tablet by mouth daily for up to 24 months
Experimental: 5
1.50 mg LY2189265 SC QW and placebo tablet 1 po qd
Drug: LY2189265
Subcutaneous injection once-weekly for up to 24 months
Other Name: Dulaglutide
Drug: Placebo tablet, 24 months
One tablet by mouth daily for up to 24 months
Experimental: 6
2.00 mg LY2189265 SC QW and placebo tablet 1 po qd
Drug: LY2189265
Subcutaneous injection once-weekly for up to 24 months
Other Name: Dulaglutide
Drug: Placebo tablet, 24 months
One tablet by mouth daily for up to 24 months
Experimental: 7
3.00 mg LY2189265 SC QW and placebo tablet 1 po qd
Drug: LY2189265
Subcutaneous injection once-weekly for up to 24 months
Other Name: Dulaglutide
Drug: Placebo tablet, 24 months
One tablet by mouth daily for up to 24 months
Active Comparator: 8
Sitagliptin 100 mg one tablet po qd and placebo solution injected SC QW
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
Placebo Comparator: 9
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
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: Sitagliptin 100 mg, 18 months
One tablet by mouth daily for up to 18 months

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734474

  Show 99 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
United BioSource Corporation
Tessella Inc.
Berry Consultants
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

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00734474     History of Changes
Other Study ID Numbers: 11422, H9X-MC-GBCF, CTRI/2009/091/000969
Study First Received: August 12, 2008
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Brazil: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Mexico: Ministry of Health
Poland: Ministry of Health
Romania: Ministry of Public Health
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014