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 May 2013 by Eli Lilly and Company
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01769378
First received: January 14, 2013
Last updated: May 14, 2013
Last verified: May 2013
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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: | August 2014 |
| Estimated Primary Completion Date: | August 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
Show 46 Study Locations
Contacts
| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
Show 46 Study LocationsSponsors 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: | May 14, 2013 |
| 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 May 19, 2013