A Study to Assess the Effect of Exenatide Treatment on Mean 24-hour Heart Rate in Patients with Type 2 Diabetes - GWCD

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-002691-33-NL
• Date of registration: 04/06/2007
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company Ltd
• Public title: A Study to Assess the Effect of Exenatide Treatment on Mean 24-hour Heart Rate in Patients with Type 2 Diabetes - GWCD
• Scientific title: A Study to Assess the Effect of Exenatide Treatment on Mean 24-hour Heart Rate in Patients with Type 2 Diabetes - GWCD
• Date of first enrolment: 11/07/2007
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002691-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients are 18 to 75 years of age
2. Patients present with type 2 diabetes based on the disease diagnostic criteria, as defined by the World Health Organization (WHO) (refer to Protocol Attachment GWCD.4.)
3. In de opinion of the investigator, it is appropriate for the patient to be treated with metformin alone, TZDx alone, of a combination of metformin and TZDs; furthermore, the patient has been treated with a stable dose of TZDs for at least 120 days. Patients who have been treated with metformin must have been on a stable dose of metformin for at least 30 days prior to screening:
- Maximally tolerated dose of metformin
- Maximally tolerated dose of rosiglitazone or pioglitazone
- Rosiglitazone or poliglitazone and metformin
4. Patients have suboptimal glycemic control at screening as evidenced by an HbA1c between 6.5% and 9.5%, inclusive.
5. Patients have a body mass index (BMI) >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. Patients who are being treated for hypertension have been on a stable regimen of antihypertensive medication for a minimum of 6 weeks prior to screening.

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. Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
9. Lilly or Amylin's employees.
10. Female patients are breastfeeding or test positive for pregnancy at the time of screening based on a blood serum test.
11. Female patients who; -intend to become pregnant during the study, - have not practiced a reliable method of birth control, - do not agree to continue to use reliable method of birth control.
12. Patients have previously receive exenatide of glucagon-like peptide-a analogs.
13 Patients have participated in an interventional medical surgical, or pharmaceutical study within 30 days of screening.
14. Patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening.
15.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.
16. Patients have had a lcinically significan history of cardiac disease or presence of active cardiac cisease within 1 yar, including myocardial infarction, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bupass surgery or angioplasty during the course of the study.
17. Patient s have a history of clinically significant arrhythmia, including, but nog limited to, a history of paroxysmal supraventricular tachycardia, artrial fibrillation, or history of any brady- or tachyarrhythmia.
18. Patients hvae a resting HR not within the normal range (60-100 bpm).
19. Patients have uncontrolled hypertension, defined as a repeatedly elevated BP exceeding 160(SBP) or 100 (DBP) mmHg.
20. Patients experience a fall in SBP>30 mmHg on standing, accompanied by symptons of dizziness, at screening.
21. Patients are receiving beta blockers.
22. Patients have a known allergy to excipients contained in exenatide.
23. Patients are using metformin alone, TZDs alone, or a combination of metformin and TZDs and have characteristics contraindicating their use, according to product-specific labels.
24. Patients have a history of renal transplantation or are currently receiving renal dialysis or have an estimated creatinine clearance of <50 mL/min, as estimated by the Cockcroft-Gault equation.
25. Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, ALT, or SGPT greater than 3 times the upper limit of the reference range.
26. Patients have known hemoglobinopathy or chronic anemia.
27. Patients are known to have active proliferative retinopahty.
28. Patients are receiving treatment with a drug directly affecting gastrointestinal motility, inckluding but nog limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
29. Patients have received treatment with systemic glucocorticoid therapy by oral, IV, or IM route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators.
30. Patients have been treated with drugs that promote weight loss within 3 months of screening.
31. Patients have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to scree

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 diabetes

Intervention(s)

Trade Name: Byetta
Product Name: exenatide
Product Code: A10BX04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: exenatide
CAS Number: 141758749
Current Sponsor code: exenatide
Other descriptive name: exendin-4, exendin 4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: To explore the effect of exenatide (BID) versus placebo (BID) treatment on change in mean 24-hour HR baseline to Week 12 of study drug exposure in patients with type 2 diabetes who have inadequate glycemic control with metformin alone, TZD's alone, or a combination of metformin and TZD's.

Primary end point(s): 24 hour ABPM after 12 weeks treated with exenatide

Secondary Objective: To compare exenatide and placebo with respect to:
-Absolute and change from baseline values of mean 24-hour HR at each measured visit.
-Absolute and change from baseline values of mean daytime and nighttime (2400-0600) HR at Week 12 and each measured visit.
-Absolute and change from baseline values of mean 24-hour SBP and DBP at Week 12 and at each measured visit.
-Absolute and change from baseline values of hemoglobin A1c (HbA1c) at endpoint (last-observation-carried-forward; LOCF).

Secondary ID(s)

H8O-MC-GWCD