ong-Term Treatment with Exenatide versus Glimepiride in Patients with Type 2 Diabetes Pretreated with Metformin - GWBE

• Conditions: Type 2 diabetes mellitus; MedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2005-005448-21-DE
• Lead Sponsor: Eli Lilly and Company Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-16
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1054

Inclusion Criteria

[1] Patients are between 18 and 85 years of age, inclusive.
[2] Patients present with type 2 diabetes based on the disease diagnostic
criteria as defined by the World Health Organization (WHO).
[3] Patients have been treated with diet and exercise, and a stable, maximally tolerated dose (in the opinion of the investigator) of immediate-release metformin or extended-release metformin for at least 3 months prior to screening.
[4] Patients have suboptimal glycemic control as evidenced by an HbA1c between =?6.5% and = 9.0%, for whom a sulfonylurea treatment is deemed appropriate in the opinion of the investigator as a next step of diabetes treatment.
[5] Patients have a body mass index =?25 kg/m2 and < 40 kg/m2.
[6] Patients have a history of stable body weight (not varying by > 10% for at least 3 months prior to screening).
[7] This inclusion criterion applies to females only:
Patients are not breastfeeding.
And
Patients of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must fulfill all of the following criteria:
o Test negative for pregnancy at the time of screening based on a serum pregnancy test.
o Do not intend to become pregnant during the study.
o Have practiced a reliable method of birth control (oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy) for 3 months prior to screening.
o Agree to continue to use a reliable method of birth control (oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy) during the study, as determined by the investigator.
Patients are eligible to be enrolled into Study Period III, that is the extension phase of the study, only if they meet the following additional inclusion criterion for Study Period III:
[8] Patients with failure of HbA1c control (primary endpoint) as defined in Section 6.1.1 during Study Period II if failure occurs 12 months or more than 12 months prior to the projected conclusion of the study.
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

[9] Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[10] Patients are employed by Lilly or Amylin (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or Amylin employees may participate in Lilly-sponsored or Lilly-managed clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[11] Patients have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
[12] Patients have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
[13] Patients have characteristics contraindicating metformin or glimepiride use, according to product-specific label.
[14] Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine =?1.5 mg/dL (132 µmol/L) for males and =?1.2 mg/dL (110 µmol/L) for females.
[15] Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, alanine aminotransaminase (ALT), or serum glutamic pyruvic transaminase (SGPT) greater than three times the upper limit of the reference range.
[16] Patients have known hemoglobinopathy or clinically significant, chronic anemia.
[17] Patients have active, symptomatic proliferative retinopathy or macular edema.
[18] Patients are receiving chronic treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility, including but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
[19] Patients have severe gastrointestinal disease, including gastroparesis.
[20] Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, nasal and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
[21] Patients have used any prescription drug to promote weight loss within 3 months prior to screening.
[22] Patients have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: Insulin; Thiazolidinediones; Alpha-glucosidase inhibitors; Sulfonylurea; Meglitinides.
[23] Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that renders them unable to understand the nature, scope, and possible consequences of the study or precludes them from following and completing the protocol, in the opinion of the investigator.
[24] Patients fail to satisfy the investigator of suitability to participate for any other reason.
Patients will be excluded from enrollment into Study Period III, that is the extension period of the study, if they meet the following additional exclusion criterion for Study Period III:
[25] Patients have charac

Study & Design

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