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

Sponsor:	Eli Lilly and Company
Collaborators:	United BioSource Corporation Tessella Inc. Berry Consultants
Information provided by (Responsible Party):	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00734474

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 II Phase III

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride

U.S. FDA Resources

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
Estimated Study Completion Date:	June 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:

(Lilly Clinical Trial Registry) This link exits the ClinicalTrials.gov site

No publications provided

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:	September 20, 2011
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 February 09, 2012