Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)

This study is currently recruiting participants.
Verified February 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01769378
First received: January 14, 2013
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide compared to placebo in participants with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Placebo
Drug: Dulaglutide
Drug: Glimepiride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Patients With Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 8)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Body Weight at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Mass Index (BMI) at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Serum Glucose at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Reported and Adjudicated Cardiovascular Events [ Time Frame: Baseline through 28 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Adjudicated Acute Pancreatitis Events [ Time Frame: Baseline through 28 Weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Calcitonin at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with Self Reported Events of Hypoglycemia [ Time Frame: Baseline through 24 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia [ Time Frame: Baseline through 24 Weeks ] [ Designated as safety issue: No ]
  • Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia [ Time Frame: Baseline through 24 Weeks ] [ Designated as safety issue: No ]
  • Dulaglutide Anti-Drug Antibodies [ Time Frame: Baseline up to 4 Weeks Post Last Dose of Study Drug ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Lipase at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 285
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Drug: Placebo
Administered SQ
Drug: Glimepiride
Administered PO
Experimental: Dulaglutide
Dulaglutide 1.5 milligram (mg) administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Drug: Dulaglutide
Administered SQ
Other Name: LY2189265
Drug: Glimepiride
Administered PO

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Stable dose of sulfonylurea that is at least 50% of the maximum approved dose per the local label for at least 3 months prior to the first study visit
  • Have an HbA1c value of ≥7.5% and ≤9.5%, as determined by the central laboratory draw performed at the first study visit
  • Accept continued treatment with sulfonylurea therapy, throughout the trial, as required per protocol
  • Men and nonpregnant women aged ≥18 years
  • Stable weight (±5%) ≥3 months prior to screening
  • Body Mass Index (BMI) ≤45 kilograms per square meter (kg/m^2)

Exclusion Criteria:

  • Have type 1 diabetes mellitus
  • Have been treated with ANY other antihyperglycemic medications (other than sulfonylurea) at the time of the first study visit or within 3 months prior to the first study visit
  • Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin within 3 months prior to the first study visit is exclusionary
  • Have been treated with drugs that promote weight loss within 3 months prior to the first study visit
  • Are receiving chronic (>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit
  • Have had any of the following Cardiovascular (CV) conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident
  • Have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level >2.5 times the upper limit of normal
  • Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit
  • Have an estimated glomerular filtration rate [eGFR] <30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2), calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation as determined by the central laboratory at the first study visit
  • Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia (this exclusion includes those participants with a family history of MEN 2A or 2B, whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation)
  • Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome)
  • Have a serum calcitonin ≥20 picogram per milliliter (pg/mL) as determined by the central laboratory at the first study visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769378

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 47 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01769378     History of Changes
Other Study ID Numbers: 13193, H9X-MC-GBDG
Study First Received: January 14, 2013
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Brazil: Ministry of Health
Mexico: Ministry of Health
South Africa: Medicines Control Council
Slovenia: Agency for Medicinal Products - Ministry of Health
Croatia: Agency for Medicinal Product and Medical Devices
Austria: Austrian Medicines and Medical Devices Agency
Romania: National Agency for Medicines and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014