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
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: 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 July 20, 2014