A Study of Dulaglutide 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:
NCT01584232
First received: April 23, 2012
Last updated: September 27, 2013
Last verified: September 2013

April 23, 2012
September 27, 2013
April 2012
July 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 NCT01584232 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Who Achieve HbA1c <=6.5% or <7% at 26 Weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Blood Glucose (FBG) at 26 Weeks [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Weight at 26 Weeks [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Hypoglycemic Episodes [ Time Frame: Baseline through 26 Weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus
A Phase 3 Study of LY2189265 Compared to Insulin Glargine in Patients With Type 2 Diabetes Mellitus on a Sulfonylurea and/or Biguanide

The purpose of this trial is to examine the efficacy and safety of once-weekly dulaglutide in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (OAM).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Dulaglutide
    Administered by SC injection.
    Other Name: LY2189265
  • Drug: Insulin glargine
    Administered by SC injection.
  • Drug: Sulfonylureas (SU)
    Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
  • Drug: Biguanide
    Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
  • Experimental: Dulaglutide + OAM
    0.75 mg dulaglutide administered once weekly as a subcutaneous (SC) injection added to participant's pre-study physician prescribed dose of SU and/or Biguanide.
    Interventions:
    • Drug: Dulaglutide
    • Drug: Sulfonylureas (SU)
    • Drug: Biguanide
  • Active Comparator: Insulin glargine + OAM
    Add Insulin glargine administered per sliding scale for 26 weeks as a once daily SC injection added to participant's pre-study physician prescribed dose of SU and/or Biguanide.
    Interventions:
    • Drug: Insulin glargine
    • Drug: Sulfonylureas (SU)
    • Drug: Biguanide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants who have had a diagnosis of type 2 diabetes mellitus for at least 6 months before screening
  • Participants who have been taking SU (Glibenclamide, Gliclazide, or Glimepiride) and/or biguanide (Metformin or Buformin). The dose of the drug(s) during the 8 weeks before screening must be stable
  • Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% at screening
  • Participants who have a body mass index (BMI) of 18.5 kg/m^2 to 35.0 kg/m^2

Exclusion Criteria:

  • Participants who have a diagnosis of type 1 diabetes
  • Participants who have previously been treated with any other GLP-1 analog
  • Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening
  • Participants who have been currently taking insulin or have had previous insulin 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
 
NCT01584232
14359, H9X-JE-GBDY
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
September 2013

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