Efficacy of once weekly exenatide long acting release and once daily insulin glargine in patients with Type 2 diabetes treated with metformin alone or in combination with sulphonylurea. - GWBR

Phase 1

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

• Registration Number: EUCTR2007-002957-22-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-28
• Study Completion: 2012-01-30
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 456

Inclusion Criteria

[1] Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO) (refer to Section 4.1.1).
[2] Are at least 18 years of age at screening.
[3] Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0%, inclusive.
[4] Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.
[5] Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
[6] Have been treated with Met for at least 3 months and have been taking a stable dose of >=1500 mg/day immediate-release Met or extended-release Met alone for at least 8 weeks prior to screening, unless lower doses are required due to tolerability concerns.
OR
Have been treated with Met for at least 3 months and have been taking a stable dose of >=1500 mg/day immediate-release Met or extended-release Met alone for at least 8 weeks prior to screening, unless lower doses are required due to tolerability concerns and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening (refer to protocol table GWBR.1).
If combined Met plus SU OAD preparations (such as Glucovance) are used, the total daily dose of each component needs to meet the criteria as outlined above.
[7] This inclusion criterion applies to females of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only.
? Are not breastfeeding.
? Test negative for pregnancy at the time of screening based on a blood serum pregnancy test.
? Intend not to become pregnant during the study.
? Have practiced a reliable method of birth control (e.g., use of oral contraceptives or approved hormonal implant; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for at least 6 weeks prior to screening.
? Agree to continue to use a reliable method of birth control (see above) during the study, as determined by the investigator.
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

[8] Are Lilly, Amylin, or Alkermes employees.
[9] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[10] Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure (New York Heart Association Class III or IV [CCNYHA 1994]), coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
[11] 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.
[12] Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >=1.5 mg/dL for males and >=1.2 mg/dL for females.
[13] Have 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.
[14] Have known hemoglobinopathy or chronic anemia (hemoglobin concentration <11.5 gm/dL [115 gm/L] for males, <10.5 gm/dL [105 gm/L] for females).
[15]Have had greater than three episodes of major hypoglycemia within 6 months prior to screening. Refer to Section 5.5.4 for more information on hypoglycemia.
[16] Have any contraindication for the OAD which they use.
[17] Have a known allergy or hypersensitivity to insulin glargine, exenatide LAR, or excipients contained in these agents.
[18] Are known to have active proliferative retinopathy.
[19] Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g., Addison disease).
[20] Have been treated with drugs that promote weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acomplia [rimonabant], Acutrim [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
[21] Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
? Insulin
o Thiazolidinediones (e.g., Actos [pioglitazone] or Avandia [rosiglitazone])
? Alpha-glucosidase inhibitors (e.g., Glyset [miglitol] or Precose [acarbose])
? Meglitinides (e.g., Prandin [repaglinide] or Starlix [nateglinide]).
? Byetta (exenatide BID formulation)
? Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia [sitagliptin], Galvus[vildagliptin])
? Symlin (pramlintide acetate).
[22] Have had an organ transplant.
[23] Have donated blood within 30 days of screening.
[24] Have previously completed or withdrawn from this study or any other study investigating exenatide LAR.
[25] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
[26] Are c

Study & Design

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