A Study of Sitagliptin/Metformin in Pediatric Patients with Type 2 Diabetes Mellitus not Controlled on Metformi
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 17.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-002529-23-LT
- Lead Sponsor
- Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
Base study:
1. Patient has type 2 diabetes mellitus (T2DM).
2. Patient has not received treatment with insulin for at least 12 weeks prior to the Screening Visit/Visit 1. However, patients who have had no more than a total of 3 days of treatment with insulin during the 12 weeks prior to the Screening Visit/Visit 1 are eligible. Note: For patients who have received treatment with insulin for more than 3 days within the 12 weeks prior to the Screening Visit/Visit 1, therapy should not be stopped (washed-off) to make them eligible for the study.
3. Patient has an A1C =6.5% and =10.0% on metformin, =1500 mg/day, for =12 weeks. Note:
-Patients on stable doses of metformin =1000 and <1500 mg/day for =12 weeks can participate if there is documentation that they cannot tolerate higher doses of metformin.
-Patients on metformin doses <1500 mg/day can have their metformin doses uptitrated to =1500 mg/day, and be eligible to participate after their dose remains stable for =12 weeks, if they meet all other eligibility criteria.
-Patients currently being treated with AHA in addition to metformin (including insulin) cannot be included in the study after wash-off.
4. Patient is =10 and =17 years of age on day of signing informed consent with randomization to occur prior to the patient’s 18th birthday.
5. Patient is either a male, or patient is a female who is unlikely to conceive as indicated by at least one yes” response to the following which will remain consistent for the projected duration of the study and for 14 days after the last dose of study medication: (a) Patient is a non-sterilized female who is currently not sexually active and agrees to follow statement c if heterosexual activity is initiated or (b) Patient agrees to abstain from heterosexual activity or (c) Patient agrees to use an adequate method of contraception.
For complete list of inclusion crtieria please refer to the protocol
Extension study:
1. Patient has completed the P170 base study on double-blind study medication.
2. Parent/guardian understands the study procedures and risks involved with the study and voluntarily agrees to the patient's participation by giving informed written consent, and the patient has an age-appropriate understanding of the same to give informed written assent. If the parent/guardian is illiterate, please see Section 3.2.3.8.1 for details.
Note: Patients, who are legally able to, should provide consent.
3. Patient and/or a family member or adult closely involved in the patient's daily activities (in the opinion of the investigator) will be available for telephone calls and study visits.
4. Patient is either a male, or patient is a female who is unlikely to conceive as indicated by at least one yes response to the following which will remain consistent for the projected duration of the study and for 14 days after the last dose of study medication: (a) Patient is a nonsterilized female who is currently not sexually active and agrees to follow statement c if heterosexual activity is
Base study:
At Visit 1
1. Patient has (1) known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when patient was diagnosed with diabetes), or (2) known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
2. Patient has symptomatic hyperglycemia and/or moderate to large ketonuria or positive test for ketonemia requiring immediate initiation of another antihyperglycemic agent.
3. Patient has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or GLP-1 receptor agonist (such as exenatide or liraglutide.
For complete list of exclusion criteria please refer to the protocol
Extension study:
1. Patient meets a discontinuation criterion of P170 at the last visit of the base study (Week 20).
2. Patient has taken the last dose of study medication for the P170 base study more than 14 days prior to Extension Visit 1.
3. Patient has initiated another open-label antihyperglycemic agent as add-on to metformin.
4. Patient does not agree to refrain from participating in any other double-blind interventional study while participating in this extension study.
5. Patient is unlikely to adhere to the study procedures and appointment schedule, has poor mental function or parent/guardian is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained.
6. Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance which, in the opinion of the investigator, might pose a risk to the patient, or make participation not in the patient's best interest.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method