A randomized, double-blind, placebo controlled, parallel group study to investigate the effect of Taspoglutide on gastric emptying measured by a paracetamol test after single dose and after multiple doses in patients with Type 2 diabetes - Gastric Emptying Study
- Conditions
- Patients with Type 2 diabetesMedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2008-003575-47-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Male or Female subject, 18 through 75 years of age, inclusive.
2. Type 2 diabetes mellitus patient.
• Fasting plasma glucose = 240 mg/dL (13.3 mmol/L) at screening.
• HbA1c = 9.5% at screening.
•Patients treated with acceptable (not excluded) stable oral antidiabetic drug therapy for at least 3 months prior to screening
3. Subject must have a Body Mass Index (BMI) > 25 kg/ m2 and = 45 kg/m2 at screening.
4. Stable weight ± 10% for at least 3 months before screening.
5. Female subject must be either postmenopausal (at least one year after the cessation of menses and confirmed by FSH > 50 UI/L or postmenopausal for more than 1 year (2 years after the cessation of menses)) or surgically sterilized (by means of hysterectomy, bilateral oophorectomies or tubal ligations) or if of childbearing potential use two medically approved birth control methods (e.g. hormonal contraceptives, IUD, barrier contraception) and be willing to use the same method of contraception during the whole course of the study and for at least 3 months after the last dose.
6. Patients able to participate and to comply with the study restrictions and have given written informed consent.
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
1. Type 1 diabetes mellitus.
2. Acute gastrointestinal symptoms at the time of screening and/or Day -1 (e.g. nausea, vomiting, diarrhea, heartburn).
3. Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases (except autonomic and/ or sensomotoric neuropathy) inclusive history of chronic pancreatitis or idiopathic acute pancreatitis.
4. Serious illness, such as active cancer, major active infection or known inflammatory process, severe psychiatric disorders at the time of the screening examination.
5. Clinically significant GI disease including but not limited to inflammatory bowel disease, irritable bowel syndrome, celiac disease, dyspepsia or surgery of the gastrointestinal tract (except appendectomy/cholecystectomy) and history of gastric bypass or antrectomy or small bowel resection.
6. History of ketoacidosis or lactic acidosis.
7. History of unstable hypertension (SBP > 170 mmHg and/or DBP > 105 mmHg), within the past 12 weeks prior to screening.
8. Known proliferative diabetic retinopathy.
9. Known hemoglobinopathy or chronic anemias.
10. Renal disease or renal dysfunction (as suggested by serum creatinine = 132 µmol/L (1.5 mg/dL) males, = 123 µmol/L (1.4 mg/dL) females at screening.
11. Clinically relevant QTc prolongation (e.g. QTc > 450 ms), family history of Long QT Syndrome, or concomitant use of Class I antiarrhythmic drugs (e.g. disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone).
12. Any clinically relevant abnormal laboratory test results or ECG (including positive test results for drugs of abuse and alcohol test) prior to first dosing, which precludes safe involvement in the study as judged by the investigator.
13. Impaired liver function (ALT or AST > 3 x ULN) at screening.
14. Subjects who test positive for HIV I and II, Hepatitis B or Hepatitis C.
15. Pregnant or lactating women.
16. History of active substance abuse (including alcohol) within the past 2 years.
17. Alcohol consumption of more than 21 or 18 units (1 unit = 10 mL of pure alcohol [UK unit]) per week for males and females respectively, or a history of alcoholism.
18. Smoking of more than 15 cigarettes a day or the equivalent amount of tobacco.
19. Treatment with exenatide or exendin analogues, GLP-1 or GLP-1 analogues at anytime during the past.
20. Treatment with weight lowering agents (e.g. orlistat, sibutramine, rimonabant, phentermine) during the last 12 weeks prior to screening.
21. Current sulfonylurea antidiabetics, acarbose, DPPIV-inhibitors.
22. Treatment with any additional oral anti-diabetic medication apart from the stable therapy (see inclusion criteria 2) and/or herbal/over the counter preparations that may affect glycemic control within 12 weeks prior to screening.
23. Treatment with insulin for more than one week within 6 months prior to screening.
24. Subjects who use drugs (including herbal drugs) known to affect gastrointestinal motility within two weeks before the first drug administration (e.g. prokinetics such as domperidone and metoclopramide, anticholinergics such as scopolamine etc.)
25. Corticosteroid treatment (>7 consecutive days of treatment) within 4 weeks prior to screening.
26. Treatment with thyroid hormones within which are not on a stable dose for at least 12 weeks prior to screening.
27. Known hypersensitivity to taspoglutide or any of the components of its formulation.
28. Participation in an investigational drug study withi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method