A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01558271
First received: March 12, 2012
Last updated: July 11, 2014
Last verified: July 2014

March 12, 2012
July 11, 2014
March 2012
October 2013   (final data collection date for primary outcome measure)
Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01558271 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Achieve HbA1c <=6.5% or <7% [ Time Frame: 26 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Blood Glucose (FBG) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Weight [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Insulin Sensitivity using Updated Homeostasis Model Assessment (HOMA 2) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Beta-cell Function using Updated Homeostasis Model Assessment (HOMA 2) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with Hypoglycemic Episodes [ Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
A Phase 3 Study of LY2189265 Monotherapy Compared to Placebo and Liraglutide in Patients With Type 2 Diabetes Mellitus

The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 in participants with type 2 diabetes mellitus who are not taking oral antidiabetic medication.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: LY2189265
    0.75 mg administered by SC injection once weekly for up to 52 weeks
    Other Name: Dulaglutide
  • Drug: Placebo
    Placebo administered by SC injection once weekly for 26 weeks
  • Drug: Liraglutide
    Liraglutide is open-label comparator in this trial. Once-daily SC injection of 0.3 mg for the first week followed by 0.6 mg for the second week, and then, 0.9 mg during the remaining treatment period.
  • Experimental: LY2189265
    Once-weekly subcutaneous (SC) injection of 0.75 mg LY2189265 for 26 weeks, followed by 0.75 mg of SC LY2189265/week for an additional 26 weeks of open therapy.
    Intervention: Drug: LY2189265
  • Placebo Comparator: Placebo
    Once-weekly SC injection of placebo for 26 weeks, followed by 0.75 mg of SC LY2189265/week for an additional 26 weeks of open therapy.
    Intervention: Drug: Placebo
  • Active Comparator: Liraglutide
    Once-daily SC injection of Liraglutide for 26 weeks, followed by once-daily SC injection of Liraglutide for an additional 26 weeks of open therapy.
    Intervention: Drug: Liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
490
May 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants who have had a diagnosis of type 2 diabetes mellitus before screening
  • Participants who have been Oral Antihyperglycemic Medication (OAM)-naïve (diet and exercise only) or been taking OAM monotherapy except for thiazolidinedione (TZD) and are willing to discontinue this medication. Participants taking OAM monotherapy must complete 8-week washout period prior to randomization.
  • Participants who are OAM naïve with screening glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% and randomization HbA1c value of 7.0% to 10.0%, or who are taking OAM monotherapy with screening HbA1c value of 6.5% to 9.0% and randomization HbA1c value of 7.0% to 10.0%.
  • Participants who have a body mass index (BMI) of 18.5kg/m^2 to 35.0kg/m^2.

Exclusion Criteria:

  • Participants who have a diagnosis of type 1 diabetes
  • Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog
  • Participants who have been receiving more than half of the maximum dose of sulfonylureas at screening.
  • Participants who have been currently taking insulin or TZD, or have had previous insulin or TZD treatment within 3 months before screening.
  • Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening.
  • Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC).
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01558271
13990, H9X-JE-GBDP
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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
July 2014

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