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

NCT ID: NCT01769378

Last Updated: 2016-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-12-31

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SQ

Glimepiride

Intervention Type: DRUG

Administered PO

Dulaglutide

Dulaglutide 1.5 milligram (mg) administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.

Group Type: EXPERIMENTAL

Dulaglutide

Intervention Type: DRUG

Administered SQ

Glimepiride

Intervention Type: DRUG

Administered PO

Interventions

Placebo

Administered SQ

Intervention Type: DRUG

Dulaglutide

Administered SQ

Intervention Type: DRUG

Glimepiride

Administered PO

Intervention Type: DRUG

Other Intervention Names

LY2189265

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Chino, California, United States

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Miami, Florida, United States

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St Louis, Missouri, United States

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Trenton, New Jersey, United States

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The Bronx, New York, United States

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Beaver, Pennsylvania, United States

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Buenos Aires, , Argentina

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Caba, , Argentina

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Corrientes, , Argentina

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Rosario, , Argentina

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Salzburg, , Austria

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Zams, , Austria

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Krapinske Toplice, , Croatia

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Osijek, , Croatia

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Rijeka, , Croatia

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Slavonski Brod, , Croatia

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Varaždin, , Croatia

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Zagreb, , Croatia

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Mexico City, , Mexico

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Tampico, , Mexico

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Alba Iulia, , Romania

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Bucharest, , Romania

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Galati, , Romania

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Iași, , Romania

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Oradea, , Romania

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Sibiu, , Romania

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Celje, , Slovenia

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Ljubljana, , Slovenia

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Bloemfontein, , South Africa

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Durban, , South Africa

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Somerset West, , South Africa

Countries

United States; Argentina; Austria; Croatia; Mexico; Romania; Slovenia; South Africa

References

Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.

Reference Type: DERIVED

PMID: 36894938 (View on PubMed)

Other Identifiers

H9X-MC-GBDG

Identifier Type: OTHER

Identifier Source: secondary_id

13193

Identifier Type: -

Identifier Source: org_study_id