E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012613 |
E.1.2 | Term | Diabetes mellitus non-insulin-dependent |
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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 |
(1) After 18 weeks, to assess the effect of the addition of sitagliptin compared with placebo on HbA1c; (2) To assess the safety and the tolerability of sitagliptin compared with placebo. |
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E.2.2 | Secondary objectives of the trial |
(1) After 18 weeks, to assess the effect of the addition of sitagliptin compared with placebo on: fasting plasma glucose (FPG); (2) After 18 weeks, to assess the effect of the addition of sitagliptin compared with placebo on 2-hour plasma glucose after a standard meal challenge. (3) After 18 weeks, to estimate the difference in effect of the addition of sitagliptin or the addition of rosiglitazone on HbA1c (4) After 18 weeks, to estimate the difference in effect of the addition of sitagliptin or the addition of rosiglitazone on body weight. (5) After 18 weeks to estimate the difference in effect of the addition of sitagliptin or the addition of rosiglitazone on LDL-C. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
a) Patient has type 2 diabetes mellitus (T2DM).
b) Patient is currently on monotherapy with metformin at a dose of >= 1500 mg/day for at least 10 weeks and has an HbA1c >= 7% and <= 11%, and will remain on a stable dose of metformin for the duration of the study
c) Patient is >= 18 and <= 75 years of age on the day of signing informed consent.
d) Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
e) Patient is male, or female who is highly unlikely to conceive, as indicated by at least one モyesヤ answer to the following questions:
1) Patient is a male.
2) Patient is surgically sterilized female.
3) Patient is a postmenopausal female >= 45 years of age with > 2 years since last menses.
4) Patient is a non-sterilized premenopausal female and agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy (either 2 barrier methods or a barrier method plus a hormonal method) or (2) to abstain from heterosexual activity throughout the study starting with Screening Visit/Visit 1 and for 14 days after the last dose of study medication. Refer to Section I.E.a) Patient has type 2 diabetes mellitus (T2DM).
b) Patient is currently on monotherapy with metformin at a dose of >= 1500 mg/day for at least 10 weeks and has an HbA1c >= 7% and <= 11%, and will remain on a stable dose of metformin for the duration of the study
c) Patient is >= 18 and <= 75 years of age on the day of signing informed consent.
d) Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
e) Patient is male, or female who is highly unlikely to conceive, as indicated by at least one モyesヤ answer to the following questions:
1) Patient is a male.
2) Patient is surgically sterilized female.
3) Patient is a postmenopausal female >= 45 years of age with > 2 years since last menses.
4) Patient is a non-sterilized premenopausal female and agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy (either 2 barrier methods or a barrier method plus a hormonal method) or (2) to abstain from heterosexual activity throughout the study starting with Screening Visit/Visit 1 and for 14 days after the last dose of study medication. Refer to Section I.E.11.a. for description of acceptable methods of contraception.
11.a. for description of acceptable methods of contraception. |
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E.4 | Principal exclusion criteria |
a) Patient participated in a sitagliptin trial (MK ヨ 0431) and received treatment with sitagliptin or blinded therapy (actual treatment not yet known to investigator).
b) Patient has presence of or a history of peripheral edema.
c) Patient is currently participating or has participated in a study with an investigational compound or device within 12 weeks of signing informed consent or plans to participate and is not willing to refrain from participating in another study.
Glucose Metabolism and Therapy Criteria
d) Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
e) Patient required insulin within the prior 8 weeks.
Patients Requiring Specific Treatments
f) Hypersensitivity or contraindication to any thiazolidinedione (e.g., rosiglitazone or pioglitazone) or biguanide (e.g., metformin) medications. Note: Contraindication based upon the label of the country of the investigational site.
g) Patient is following a weight loss program and is not in a weight-stable phase.
h) Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks or plans to initiate weight loss medication during the study.
i) Patient has had a change in their lipid-altering medication or thyroid medication regimen (e.g., new medication or dose change) within the 5 weeks prior to Visit 1 or requires a change in their lipid-altering or thyroid regimen based upon Visit 1 (or Visit 2, if patient was not fasting, and lipid results obtained at Visit 2) laboratory results.
Note: patients may be re-screened when on a stable regimen for at least 5 weeks.
j) Patient is on or likely to require treatment with >=14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
k) Patient is on or likely to require an immunosuppressive/immunomodulating agent (e.g., cyclosporin, methotrexate, etanercept).
l) Patient has undergone surgery requiring general anesthesia within the prior 30 days or patient has planned surgery. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |