A Randomized Trial Comparing Exenatide with Placebo in Subjects with Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications - GWCO

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2008-003843-36-GR
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

[1] Have T2DM
[2] Are at least 18 years of age
[3] Have been taking basal insulin glargine at a dose of =20 units/day for at least 3 months prior to Visit 1
[4] Have been receiving glargine alone or in combination with one of the following OAM regimens for the 3 months prior to Visit 1:metformin,pioglitazone, a combination of metformin and a pioglitazone at a stable dose for 6 weeks prior to Visit 1 and do not meet exclusion criteria 11.
[5] Have an A1C =7.1% and =10.5%.
[6] Have a body mass index (BMI) =45 kg/m2.
[7] Show no evidence of cardiovascular disease as determined by a normal electrocardiogram (ECG)
[8] Have a history of stable body weight
[9] Liver enzyme tests (ALT, AST) are not greater than 1.5 times the upper limit of the reference range
[10] Are female subjects with serum creatinine level =1.4 mg/dL or male
subjects with serum creatinine level =1.5 mg/dL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[11] Are currently taking a dose or combination of OAM that is not allowed with concurrent use of insulin glargine per local product label
[12] Have taken any glucose-lowering medications not included in
Inclusion Criteria [3] and [4] in the 3 months prior to Visit 1 for more than 1 week or within 1 month of screening.
[13] Have taken any insulin other than glargine within the 3 months prior to Visit 1 for more than 1 week or within 1 month of screening
[14] Have had more than one episode of major hypoglycemia, within 6 months prior to Visit 1
[15] Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
[16] Women who are breastfeeding.
[17] presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic,
gastrointestinal disease, or any other serious disease
[18] Have a history of renal transplantation or receiving dialysis
[19] Are subjects with a malignancy (see protocol for specifics)
[20] Have contraindication or known hypersensitivity or allergy to exenatide or to any of the product components
[21] Have used a drug for weight loss within 3 months prior to Visit 1 for more than 1
week or within 1 month of screening
[22] Are currently on a supervised weight-loss program
[23] Have had a blood transfusion or severe blood loss within 3 months prior to Visit 1 or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other condition known to interfere with the A1C methodology.
[24] Are receiving chronic systemic glucocorticoid therapy or have received such therapy within the 8 weeks immediately preceding Visit 1.
[25] Have an irregular sleep/wake cycle
[26] Have any other condition that renders the subject unable to understand the
nature, scope, and possible consequences of the study,
[27] Have received treatment within 30 days before Visit 1 with a drug that has not received regulatory approval for any indication at the time of study entry.
[28] Are investigator site personnel directly affiliated with this study and/or their immediate families.
[29] Are employed by Lilly or Amylin Pharmaceuticals, Inc.
[30] Have previously completed or withdrawn from this study after signing
the ICD.
[31] If on metformin and have contraindication to metformin use
[32] If on metformin, have had a radiologic contrast study performed within 48 hours prior to Visit 1.
[33] If on pioglitazone, have a contraindication to pioglitazone including NYHA Class II-IV CHF or are on a dose of pioglitazone that is contraindicated with insulin in that country.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified