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:
NCT01468181
First received: November 7, 2011
Last updated: April 14, 2014
Last verified: December 2013

November 7, 2011
April 14, 2014
November 2011
December 2013   (final data collection date for primary outcome measure)
  • Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Hypoglycemic Episodes [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01468181 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Achieve HbA1c <=6.5% or <7% [ Time Frame: 26 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Fasting Blood Glucose (FBG) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Body Weight [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Updated Homeostasis Model Assessment (HOMA 2) [ Time Frame: Baseline, 26 weeks, 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 52-Week, Open-Label, Long-Term Safety Study of LY2189265 in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus

52 week, multicenter, non-randomized, open-label, phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: LY2189265
    0.75 mg administered by subcutaneous injection once weekly for 52 weeks
    Other Name: dulaglutide
  • Drug: Sulfonylureas (SU)
    SU is pre-study prescribed dose, and is not being provided as part of the trial.
  • Drug: Biguanides
    Biguanides is pre-study prescribed dose, and is not being provided as part of the trial.
  • Drug: Thiazolidinedione (TZD)
    TZD is pre-study prescribed dose, and is not being provided as part of the trial.
  • Drug: alpha-glucosidase inhibitor (a-GI)
    a-GI is pre-study prescribed dose, and is not being provided as part of the trial.
  • Drug: Glinides
    Glinides is pre-study prescribed dose, and is not being provided as part of the trial.
  • Experimental: Sulfonylureas (SU)+ LY2189265
    Add LY2189265 to participant's pre-study physician prescribed dose of SU monotherapy
    Interventions:
    • Drug: LY2189265
    • Drug: Sulfonylureas (SU)
  • Experimental: Biguanides+ LY2189265
    Add LY2189265 to participant's pre-study physician prescribed dose of Biguanides
    Interventions:
    • Drug: LY2189265
    • Drug: Biguanides
  • Experimental: Thiazolidinedione (TZD)+ LY2189265
    Add LY2189265 to participant's pre-study physician prescribed dose of TZD monotherapy
    Interventions:
    • Drug: LY2189265
    • Drug: Thiazolidinedione (TZD)
  • Experimental: alpha-glucosidase inhibitor (a-GI)+LY2189265
    Add LY2189265 to participant's pre-study physician prescribed dose of a-GI monotherapy
    Interventions:
    • Drug: LY2189265
    • Drug: alpha-glucosidase inhibitor (a-GI)
  • Experimental: Glinides+ LY2189265
    Add LY2189265 to participant's pre-study physician prescribed dose of Glinides monotherapy
    Interventions:
    • Drug: LY2189265
    • Drug: Glinides
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
365
December 2013
December 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 taking SU (Glibenclamide, Gliclazide, Glimepiride), biguanides, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening
  • Participants must have a qualifying HbA1c value of 7.0% to 11.0% 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 glucagon-like peptide-1 (GLP-1) analog within the 3 months before screening
  • Participants who are currently taking insulin or have had previous insulin treatment within the 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
 
NCT01468181
13991, H9X-JE-GBDQ
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 9AM-5PM Eastern time (UTC/GMT - 5, hours, EST) Eli Lilly and Company
Eli Lilly and Company
December 2013

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