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

August 12, 2008
August 9, 2012
August 2008
June 2011   (final data collection date for primary outcome measure)
HbA1c change from baseline [ Time Frame: over 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00734474 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: LY2189265
    Subcutaneous injection once-weekly for up to 24 months
    Other Name: Dulaglutide
  • 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
  • Experimental: 1
    0.25 mg LY2189265 Subcutaneous (SC) once weekly (QW) and placebo tablet 1 po qd
    Interventions:
    • Drug: LY2189265
    • Drug: Placebo tablet, 24 months
  • Experimental: 2
    0.50 mg LY2189265 SC QW and placebo tablet 1 po qd
    Interventions:
    • Drug: LY2189265
    • Drug: Placebo tablet, 24 months
  • Experimental: 3
    0.75 mg LY2189265 SC QW and placebo tablet 1 po qd
    Interventions:
    • Drug: LY2189265
    • Drug: Placebo tablet, 24 months
  • Experimental: 4
    1.00 mg LY2189265 SC QW and placebo tablet 1 po qd
    Interventions:
    • Drug: LY2189265
    • Drug: Placebo tablet, 24 months
  • Experimental: 5
    1.50 mg LY2189265 SC QW and placebo tablet 1 po qd
    Interventions:
    • Drug: LY2189265
    • Drug: Placebo tablet, 24 months
  • Experimental: 6
    2.00 mg LY2189265 SC QW and placebo tablet 1 po qd
    Interventions:
    • Drug: LY2189265
    • Drug: Placebo tablet, 24 months
  • Experimental: 7
    3.00 mg LY2189265 SC QW and placebo tablet 1 po qd
    Interventions:
    • Drug: LY2189265
    • Drug: Placebo tablet, 24 months
  • Active Comparator: 8
    Sitagliptin 100 mg one tablet po qd and placebo solution injected SC QW
    Interventions:
    • Drug: Sitagliptin 100mg, 24 months
    • Drug: Placebo solution
  • 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
    Interventions:
    • Drug: Placebo solution
    • Drug: Placebo tablet, 6 months
    • Drug: Sitagliptin 100 mg, 18 months
Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1566
July 2012
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany,   India,   Korea, Republic of,   Mexico,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Taiwan
 
NCT00734474
11422, H9X-MC-GBCF, CTRI/2009/091/000969
Yes
Eli Lilly and Company
Eli Lilly and Company
  • United BioSource Corporation
  • Tessella Inc.
  • Berry Consultants
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
Eli Lilly and Company
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP