| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
type II diabetes mellitus
Diabetes Mellitus Tipo II |
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| 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 |
(1) After 30 weeks, to assess the effect of the addition of sitagliptin compared with glimepiride on HbA1c.
(2) To assess the safety and the tolerability of sitagliptin compared with glimepiride.
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| E.2.2 | Secondary objectives of the trial |
After 30 weeks, to assess the effect of the addition of sitagliptin compared with glimepiride on:
(1) The incidence of hypoglycemic events
(2) Body weight
(3) Fasting plasma glucose (FPG).
(4) Proportion of patients achieving at goal HbA1c (<6.5%, <7.0%).
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Patient has T2DM.
2. Patient is ³18 years of age on day of signing informed consent.
3. Patient is on a stable dose and is expected to be able to remain on stable dose of metformin (at a dose of at least 1500 mg per day, for at least 12 weeks) with inadequate glycemic control, i.e., HbA1c ≥ 6.5% and ≤ 9.0%.
4. Patient understands the study procedures, alternative treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
5. Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period.
6. Patient is unlikely to conceive, as indicated by at least one “yes” answer to the following questions:
a. Patient is a male.
b. Patient is a surgically sterilized female.
c. Patient is a postmenopausal female ³45 years of age with >2 years since last menses
d. Patient is a non-sterilized premenopausal female and agrees to abstain from heterosexual activity or to use an adequate method of contraception to prevent pregnancy.
Note: Acceptable methods of birth control are: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermacide, contraceptive sponge, condom, or vasectomy.
At Visit 3
7. Patient has ³85% compliance (as measured by tablet count) with single-blind placebo tablets during run-in.
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| E.4 | Principal exclusion criteria |
History of type 1 diabetes mellitus or ketoacidosis.
Patient has been on an investigational or approved DPP-4 inhibitor agent, a sulfonylurea agent, a meglitinide agent, biguanides other than metformin, α-glucosidase inhibitors, GLP-1 analogues (e.g., exenatide), PPARγ agents or insulin, within the prior 12 weeks.
Patient has a hypersensitivity or contraindication to any sulfonylurea.
Patient is on a weight loss program and is not in the maintenance phase or patient has started on a weight loss medication within the prior 8 weeks.
Patient is on or likely to require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
Patient is on or likely to require an immunosuppressive/immunomodulating agent.
Patient has undergone surgery requiring general anesthesia within the prior 30 days or patient has planned surgery.
Patient has received treatment with an investigational drug within the prior 8 weeks.
Patient has a serum ALT or AST >2.0-fold the Upper Limit of Normal (ULN).
Patient has either serum creatinine ≥ 1.4 mg/dL (123.8 μmol/L) in men and ≥ 1.3 mg/dL (114.9 μmol/L) in women or estimated creatinine clearance (using Cockcroft-Gault formula) <60 mL/min.
Patient has inadequately controlled hypertension.
Patient has a triglyceride (TG) >500 mg/dL (6.78 mmol/L).
Patient has a TSH value outside of the laboratory normal range.
Patient has cirrhosis or active liver disease.
Patient has any of the following disorders within the past 12 weeks:
Acute coronary syndrome or new or worsening symptoms of coronary heart disease
Coronary artery intervention
Stroke or transient ischemic neurological disorder
Patient has severe peripheral vascular disease.
Patient has congestive heart failure requiring pharmacological therapy or any other condition(s) for which metformin is contraindicated according to the approved metformin label in the country in which the study site is located.
Patient is HIV positive.
Patient has a clinically important hematological disorder.
Patient has a positive urine pregnancy test.
Patient has a history of malignancy.
At Visit 2, Patient has a FPG consistently <110 mg/dL (6.11 mmol/L) or >240 mg/dL (13.33 mmol/L).
At Visit 3, Patient has a site fasting fingerstick <110 mg/dL (6.11 mmol/L) or >240 mg/dL (13.33 mmol/L).
Patient has a body mass index (BMI) < 20 kg/m2 OR >40 kg/m2.
Patient is not willing to comply with restrictions on alcohol (regular intake of £2 drinks per day and no more than 14 drinks per week).
Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
Patient has any other condition or therapy which, in the opinion of the investigator or Merck medical monitor, might pose a risk to the patient or make participation not in the patient’s best interest.
Patient has poor mental function or any other reason to expect that the patient may have difficulty in complying with the requirements of the study. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Endpoint: HbA1c.
Secondary Endpoints: FPG
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Information not present in EudraCT |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| 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 | Yes |
| 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 | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 55 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 9 |
| 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 | 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
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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 | 1 |
| E.8.9.1 | In the Member State concerned months | 10 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 10 |
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