| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Type 2 Diabetes Mellitus (T2DM) |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 12.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10067585 |
| E.1.2 | Term | Type 2 diabetes mellitus |
|
| 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 |
| After 26 weeks, in patients with T2DM with inadequate glycemic control on metformin monotherapy: To assess the effect of a sitagliptin-based treatment paradigm compared with a liraglutide-based treatment paradigm on A1C |
|
| E.2.2 | Secondary objectives of the trial |
After 26 weeks, to assess the effect of a sitagliptin-based treatment paradigm compared with a liraglutide-based treatment paradigm:
1) on fasting plasma glucose (FPG).
2) on the proportion of patients at the glycemic goals of A1C <7.0% and <6.5%. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
At Visit 1 /Screening Visit
1. Patient has T2DM and is ≥18 and ≤79 years of age on the day of signing the informed consent form.
2. Patient is on a stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and has an A1C ≥7.0% and ≤11.0% at Visit 1/ Screening Visit.
3. Patient is a male, or a female who is highly unlikely to conceive as indicated by at least one "yes" answer to the following questions:
a. Patient is a female who is not of reproductive potential. A female patient who is not of reproductive potential is defined as one who has either (1) reached natural menopause (defined as ≥6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory, or ≥12 months of spontaneous amenorrhea in women >45 years of age), or (2) undergone bilateral oophorectomy and/or hysterectomy, or bilateral tubal ligation.
b. Patient is of reproductive potential and agrees to remain abstinent (where approved by IRB/ERCs as method of contraception) or use (or have their partner use) an acceptable method of birth control within the projected duration of the study and for 14 days after the last dose of study medication. Acceptable methods of birth control are: hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
4. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving informed written consent.
5. Patient is deemed capable by the investigator of using a liraglutide pen device.
|
|
| E.4 | Principal exclusion criteria |
At Visit 1/ Screening Visit
Glucose Metabolism and Therapy Criteria
1. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis or patient is assessed by the investigator as possibly having type 1 diabetes mellitus confirmed with a C-peptide <0.7 ng/mL (<0.23 nmol/L).
Note: Only patients assessed by the investigator as possibly having type 1 diabetes mellitus should have C-peptide measured at Visit 1/Screening Visit.
2. Patient has been treated with any AHA therapies other than metformin monotherapy within the prior 12 weeks of Visit 1/Screening Visit.
Note: Patients who have received a brief period of insulin treatment and who no longer require insulin treatment may participate.
Patients Requiring Specific Treatments
3. Patient is currently participating in or has participated in another study with an investigational compound/ device within the prior 12 weeks of signing the informed consent or does not agree to refrain from participating in any other study while participating in this study.
4. Patient has a history of hypersensitivity or any contraindication to sitagliptin, liraglutide, glimepiride, or metformin based upon the labels of the country of the investigational site.
5. Patient is on a weight loss program and not in the maintenance phase or has started a weight loss medication within the prior 8 weeks.
6. Patient has undergone surgery within the prior 4 weeks or has major surgery planned during the study.
Note: Patients who have undergone minor surgery within the prior 4 weeks and are fully recovered or patients who have planned minor surgery may participate.
7. Patient is on or is likely to require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
Note: Inhaled, nasal, and topical corticosteroids are permitted.
Concomitant Conditions or Diseases of Organs and Systems
8. Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months, or had any of the following within the past 3 months:
a. Acute coronary syndrome
b. Coronary artery intervention
c. Stroke or transient ischemic neurological disorder
9. Patient has severe active peripheral vascular disease
10. Patient has a history of malignancy or clinically important hematological disorder which requires disease-specific treatment or, in the opinion of the investigator, is likely to recur during the duration of the study.
Exceptions: Patients with a history of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, or malignant melanoma, are ineligible for the study regardless of the time since treatment.
11. Patient has a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
Exclusion Criteria Based on Laboratory Abnormalities
12. Patient has exclusionary laboratory values as listed in the protocol
Other Criteria
13. Patient is pregnant or breastfeeding or is intending to become pregnant or donate eggs within the projected duration of the study and poststudy follow-up period.
14. Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug abuse or increased alcohol consumption.
Note: For the purpose of this study, increased alcohol consumption includes alcohol intake as defined by >2 drinks per day or >14 drinks per week, or binge drinking.
15. Patient has a history or new evidence of any condition, laboratory abnormality or other circumstance that will require intervention during the study, or that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study.
At Visit 2/Day 1
16. Patient has a history or new evidence of any condition, laboratory abnormality or other circumstance that will require intervention during the study, or that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study.
Note: This includes assessment of ECG performed at Visit 2/Day 1; ECG must be read before the patient is randomized.
17. Patient has a positive urine pregnancy test.
Note: Urine pregnancy test is required to be performed before the patient is randomized.
18. Patient has a FFSG ≥270 mg/dL (>15.0 mmol/L).
Note: If the patient meets this exclusion criterion, a single repeat site fingerstick glucose measurement may be performed within 7 days at the investigator’s discretion if he/she believes that the value does not reflect the patient’s recent glycemic control based upon patient self-monitoring blood glucose values and/or the Visit 1/ Screening Visit FPG value. The current visit should be changed to an Unscheduled Visit, and the patient should be rescheduled for Visit 2/Day 1. If at the rescheduled Visit 2/Day 1, the patient’s repeat measurement meets the exclusion criterion, the patient MUST be excluded.
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| A1C change from baseline at Week 26 |
|
| 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 | 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) | 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 | 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 | Yes |
| E.8.2.3.1 | Comparator description |
| Liraglutide is an injection/pre-filled pen |
|
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 68 |
| 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 |
|
| 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
|
|
| 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 | 2 |
| E.8.9.1 | In the Member State concerned days | 0 |
| 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 | 2 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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