A 34-week Follow-up to: A Study of Sitagliptin/Metformin in Pediatric Patients with Type 2 Diabetes Mellitus not Controlled on Metformin Therapy (Alone or in Combination with Insulin).
- Conditions
- Type 2 Diabetes MellitusTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-003583-20-GB
- 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
- 140
1. Patient has completed the P170 base study.
NOTE: Patients may participate in the extension study on or off 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. 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 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 Note: If abstinence is not a locally acceptable method of contraception, then one other adequate birth control method must be used, or
c) Patient agrees to use an adequate method of contraception. Note: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. Adequate methods of birth control are: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, or use of condom by the partner. Patients initiating hormonal contraception during the study should use one additional method during the first 2 months.
Are the trial subjects under 18? yes
Number of subjects for this age range: 140
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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 oral antihyperglycemic agent (i.e other than study medication or 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.
At Extension Visit 1
1. Patient does not agree to refrain from participating in any other double-blind interventional study while participating in the P170 extension study.
2. 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.
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