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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
EUCTR2008-001765-28-SK |
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Date of registration:
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09/07/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of taspoglutide (RO5073031) compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise
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Scientific title:
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A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of taspoglutide (RO5073031) compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise |
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Date of first enrolment:
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09/10/2008 |
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Target sample size:
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330 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001765-28 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Slovakia
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Men and women, aged 18 - 80 years at screening. Women of childbearing potential using two medically approved birth control methods (e.g. hormonal contraceptives, IUD, barrier contraception) must be willing to use the same methods of contraception during the whole course of the study.
2. Patients diagnosed with type 2 diabetes and uncontrolled with diet and exercise. Drug naive patients (defined as no treatment with an oral antidiabetic agent for at least 12 weeks prior to screening and no treatment with oral antidiabetic agents for more than 3 consecutive months at any time in the past).
3. Tested negative for anti-GAD antibodies.
4. C-peptide (fasting) =1.0 ng/ml.
5. HbA1c: =6.5 and =10.0 % at screening.
6. Body mass index (BMI) =25 (>23 for Asians) and =45 kg/m2 at screening.
7. Stable weight ± 5% for at least 12 weeks prior to screening.
8. Agreement to maintain prior diet and exercise habits during the full course of the study.
9. Ability and willingness to give written informed consent and to comply with the requirements 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:
1. Women who are pregnant, intending to become pregnant during the study period or currently lactating females.
2. Diagnosis of or history of:
a. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acromegaly and Cushing’s Syndrome.
b. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.
3. Evidence of clinically significant diabetic complications.
4. Symptomatic poorly controlled diabetes.
5. Clinically symptomatic gastrointestinal (GI) disease including but not limited to inflammatory bowel disease, celiac disease, diabetic gastroparesis.
6. History of gastric bypass or anthrectomy, or small bowel resection.
7. History of chronic pancreatitis or idiopathic acute pancreatitis.
8. Myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months.
9. Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by the Investigator.
10. Clinically relevant QTc prolongation (e.g. QTc > 480 ms), family history of Long QT Syndrome, or concomitant use of Class I antiarrhythmic drugs (e.g. disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone).
11. Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix or in situ prostate cancer) within the past 5 years.
12. Known hemoglobinopathy or chronic anemia.
13. Donation of one unit (500 ml) or more blood, significant blood loss equalling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
14. Any concurrent medical condition/disorder that, in the opinion of the Investigator, is likely:
- to interfere with the patient’s ability to complete the entire study period or to participate in all aspects of the trial,
- to require, during the study, the administration of a treatment that would affect the interpretation of the efficacy and safety data.
15. Treatment with any oral anti-diabetic medication and/or herbal/over the counter preparations that may affect glycemic control within 12 weeks prior to screening.
16. Treatment with exenatide or exendin analogues, GLP-1 or GLP-1 analogues at anytime during the past.
17. Treatment with insulin (except during pregnancy) for more than one week within 6 months prior to screening.
18. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 4 weeks prior to screening.
19. Treatment with weight lowering agents (e.g. orlistat, sibutramine, rimonabant, phentermine) during the last 12 weeks prior to screening.
20. History of unstable hypertension (SBP >170 mmHg and/or DBP >105 mmHg) within the past 12 weeks prior to screening.
21. Treatment with anti-hypertensive medications which are not on a stable dose for at least 4 weeks prior to baseline.
22. Treatment with lipid lowering medications which are not on a stable dose for at least 8 weeks prior to screening.
23. Treatment with thyroid hormones which are not on a stable dose for at least 12 weeks prior to screening.
24. Use of investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening unless local health authority guidelines mandate a longer period.
25. Any of the following laboratory abnormalities at screening:
a. ALT and/or AST > 3 times the upper limit of the normal range;
a. serum creatinine le
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Type 2 diabetes mellitus
MedDRA version: 9.1
Level: LLT
Classification code 10012601
Term: Diabetes mellitus
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Intervention(s)
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Product Name: TASPOGLUTIDE
Product Code: RO5073031
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TASPOGLUTIDE
Current Sponsor code: RO5073031
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: TASPOGLUTIDE
Product Code: RO5073031
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TASPOGLUTIDE
Current Sponsor code: RO5073031
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Main Objective: The primary objective is to determine the efficacy of taspoglutide based on glycemic control (as assessed by HbA1c) compared with placebo in drug-naïve patients with type 2 diabetes after 24 weeks of treatment
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Secondary Objective: The secondary objectives of the study are to determine:
• Absolute/% change from baseline in fasting plasma glucose (FPG).
• Absolute/% change from baseline in body weight.
• Absolute/% change from baseline in fructosamine.
• Responder rates, defined as target HbA1c: = 7.0 %, = 6.5%.
• Beta cell function (indexed by fasting pro-insulin conc., fasting pro-insulin/insulin ratio, homeostasis model assessment of ß-cell function (HOMA-B).
• Meal test in a subset of patients: change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test (7 time-points over 3 hours).
• 24-hr blood glucose profile (based on 7-point sampling).
• The safety and tolerability of taspoglutide versus placebo.
• The pharmacokinetics of taspoglutide
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Primary end point(s): Absolute change from baseline in HbA1c
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 09/10/2008
Contact:
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