Comparison of Dulaglutide with Placebo in Pediatric Patients with Type 2Diabetes Mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2017/08/009266
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1.Are male or female children and adolescents aged 10 to <18 years at randomization.
2.Have T2DM as diagnosed by Global International Diabetes Foundation/International Society for Pediatric and Adolescent Diabetes (IDFISPAD;
IDF 2011 [WWW]) criteria
3. Have T2DM treated at the time of randomization with lifestyle measures(standardized diet and exercise program), with or without metformin
(�1000 mg/day, unless the patient has documented intolerance of metformin, in which case the highest tolerated dose will be used, and not more than the locally approved dose), and/or basal insulin therapy. Doses of metformin and basal
insulin must have been stable (�±15%) for at least 8 weeks prior to screening visit. Lifestyle measures must have been in place for at least 8 weeks prior to the screening visit.
4.Have HbA1c >6.5% to ïâ??£11.0% at screening visit, unless a patient is newly diagnosed and only treated with lifestyle measures, in which case the HbA1c should be >6.5% to ïâ??£9.0%.
5.Have BMI >85% percentile of the general age- and gender-matched population for that country or region and body weight �50 kg.
6. Both the child or adolescent with T2DM and a parent or legal guardian are able to understand and fully participate in the activities of the clinical trial and sign their assent and consent, respectively.
1. Have a history of diabetic ketoacidosis after receiving antidiabetes medication.
2. Have diabetes-associated autoantibodies (GAD65 or IA2), historically or at screening.
3. Have a clinically significant gastric emptying abnormality, in the opinion of the investigator, or previous gastric bypass.
4. Have prior chronic, recurrent, or idiopathic pancreatitis; known gallbladder disease; or clinical hypertriglyceridemia associated with pancreatitis, i.e., >11.2 mmol/L ( >1000 mg/dL), historically or at screening.
5. Have a known self or family history of multiple endocrine neoplasia (MEN)type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma.
6. Have a serum calcitonin �20 pg/mL at screening, as determined by the central laboratory.
7. (eGFR) <60 mL/min at screening.
8. Have recurrent severe hypoglycemia or hypoglycemic unawareness as judged by the investigator.
9. Have blood pressure above the 99th percentile for age and gender in children OR systolic blood pressure �160 mm Hg or diastolic blood pressure
�100 mmHg at screening.
11. Have an active or treated malignancy.
12. Have a hemoglobinopathy or other disorder that interferes with the accurate determination of the primary endpoint, including, but not limited to, patients with the following hemoglobin variants: HbS, HbC, HbE, HbSC, and elevated HbF.
13. For females of childbearing potential: Are sexually active and not on either 1 highly effective form of contraception or 2 effective forms of contraception
14.For females of childbearing potential: Are pregnant or intending to become pregnant.
15.For females of childbearing potential: Are breastfeeding.
16. Are known to or are suspected of chronically abusing alcohol or drugs/narcotics.
17. Have known T1DM.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to test the hypothesis that dulaglutide (0.75 mg and 1.5 mg, <br/ ><br>pooled) given subcutaneously (SC) once a week for 26 weeks to children and adolescents with type 2 diabetes <br/ ><br>mellitus (T2DM) who have inadequate glycemic control, despite diet and exercise, with or without metformin <br/ ><br>and/or basal insulin, is superior to placebo in the treatment of T2DM, as measured by baseline to Week 26 change <br/ ><br>in hemoglobin A1cTimepoint: Change in hemoglobin A1c from baseline to Week 26
- Secondary Outcome Measures
Name Time Method To compare the dulaglutide 0.75 mg and dulaglutide 1.5 mg arms <br/ ><br>(individually and pooled) to placebo with respect to the parameters mentioned belowTimepoint: 1.Change in HbA1c between baseline and Week 26 (individual doses only) <br/ ><br>2.Change in fasting blood glucose (FBG) between baseline and Week 26 <br/ ><br>3.Percentage of patients with HbA1c �6.5% at Week 26 <br/ ><br>4.Change in body mass index (BMI) between baseline and Week 26