A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01644500
First received: July 17, 2012
Last updated: August 22, 2014
Last verified: August 2014

July 17, 2012
August 22, 2014
July 2012
August 2014   (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 NCT01644500 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Attaining HbA1c of <7% or ≤6.5% 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 7-point self-monitored blood glucose (SMBG) profiles at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Homeostasis Model Assessment 2 steady-state Beta (β) - cell function (HOMA2-%B) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Rate of Hypoglycemic Episodes [ Time Frame: Baseline through 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Homeostasis Model Assessment 2 insulin sensitivity - cell function (HOMA2-%S) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus
The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to glimepiride in participants with type 2 diabetes who have inadequate glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Dulaglutide
    Administered SC
    Other Name: LY2189265
  • Drug: Glimepiride
    Administered orally
  • Drug: Placebo
    Placebo for Dulaglutide is administered as one SC injection. Placebo for Glimepiride is administered as one to three capsules daily.
  • Experimental: 1.5 mg Dulaglutide
    1.5 milligrams (mg) Dulaglutide administered as one subcutaneous (SC) injection once-weekly plus one to three capsules of placebo each day for blinding purposes.
    Interventions:
    • Drug: Dulaglutide
    • Drug: Placebo
  • Experimental: 0.75 mg Dulaglutide
    0.75 mg Dulaglutide administered as one SC injection once- weekly plus one to three capsules of placebo each day for blinding purposes.
    Interventions:
    • Drug: Dulaglutide
    • Drug: Placebo
  • Active Comparator: Glimepiride
    1 to 3 mg/day Glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes.
    Interventions:
    • Drug: Glimepiride
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
789
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • OAM-naïve or have been taking OAM monotherapy for at least 3 months
  • Glycosylated Hemoglobin (HbA1c) value of ≥7.0% to ≤10.5% for OAM-naïve participant or ≥6.5% to ≤10.0% for participant taking OAM monotherapy
  • Adult men or adult non-pregnant, non-breastfeeding women
  • Stable weight (±5%) ≥3 months prior to screening
  • Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m^2)

Exclusion Criteria:

  • Have type 1 diabetes mellitus
  • Have previously been treated with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic during the 3 months before screening
  • Are currently taking dipeptidylpeptidase-IV (DPP-IV) inhibitor and thiazolidinediones (TZD) during the 3 months before screening
  • Have gastric emptying abnormality
  • Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke
  • Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of mercury [mmHg] or diastolic blood pressure above 95 mmHg)
  • Impaired liver function
  • Impaired kidney function
  • Have history of chronic pancreatitis or acute pancreatitis
  • Have a serum calcitonin ≥20 picogram/milliliter (pg/mL)
  • Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma or multiple endocrine neoplasia type 2 (MEN 2)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Taiwan,   Korea, Republic of
 
NCT01644500
11991, H9X-JE-GBCG
Yes
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
August 2014

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