E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes mellitus. |
Typ 2 diabetes mellitus. |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes mellitus. |
Typ 2 diabetes mellitus |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To examine the acute effect of sitagliptin as a single dose on insulin and glucose levels after ingestion of a standardized mixed meal in men with type 2 diabetes. |
|
E.2.2 | Secondary objectives of the trial |
To examine the acute effect of sitagliptin as a single dose on glucagon, activa and total GIP, activa and total GLP-1 levels and insulin secretory rate after ingestion of a standardized mixed meal in men with type 2 diabetes. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Caucasian men with type 2 diabetes diagnosed according to ICD10
• Ongoing treatment with life style adjustment or life style adjustment together with metformin as oral antidiabetic . Metformin therapy should not exceed 2 grams daily
• Age 20-75 years
• HbA1c ≤80 mmol/mol
• BMI: 20-40 kg/m2
• Written informed consent has been given
• Capability and willingness to participate in the whole study
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E.4 | Principal exclusion criteria |
• Liver disease or ALAT three times above upper reference range
• Diabetic nephropathy (GFR < 50 ml/min/1.73 m2 or albuminuria)
• Proliferative diabetic retinopathy
• Treatment with any glucose-lowering medication except metformin
• Previous myocardial infarction, coronary heart disease or insatiable angina pectoris in the last 6 months.
• Previous surgery on the gastrointestinal tract
• Larger surgical intervention during the last 12 weeks
• Treatment with oral steroids or thiazide diuretics
• Treatment with digoxin
• Smokers
• Participation in another study the last 4 weeks
• Paracetamol intolerance
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E.5 End points |
E.5.1 | Primary end point(s) |
• The area under the 180 min curves for plasma insulin concentrations
• The area under the 180 min curves for plasma glucose
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
0-180 min after meal ingestion |
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E.5.2 | Secondary end point(s) |
- The area under the 180 min curves for glucagon, total and intact GIP and total and intact GLP-1 concentrations
- The area under the 30 min curves for insulin, glucagon, total and intact GIP and total and intact GLP-1 concentrations
- Ratio of area under the curves (180 min) for intact to total GIP and GLP-1
- Insulin secretion rate and glucose sensitivity of the ß-cells as determined by C-peptide convolution of the data.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0-180 min after meal ingestion |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial is the last visit of the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |