Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Dulaglutide: Two doses of dulaglutide (0.75 mg/week and 1.5 mg/week) and placebo will be used in the 26-week double-blind
period of the trial. Following this, during the 26-week open-la
Sponsors
Eli Lilly and Company India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Are male or female children and adolescents aged 10 to 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 (ââ?°Â¥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 (Ã?±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 ââ?°Â¥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.
Exclusion criteria
Exclusion criteria: 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to test the hypothesis that dulaglutide (0.75 mg and 1.5 mg, pooled) given subcutaneously (SC) once a week for 26 weeks to children and adolescents with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control, despite diet and exercise, with or without metformin and/or basal insulin, is superior to placebo in the treatment of T2DM, as measured by baseline to Week 26 change in hemoglobin A1cTimepoint: Change in hemoglobin A1c from baseline to Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the dulaglutide 0.75 mg and dulaglutide 1.5 mg arms (individually and pooled) to placebo with respect to the parameters mentioned belowTimepoint: 1.Change in HbA1c between baseline and Week 26 (individual doses only) 2.Change in fasting blood glucose (FBG) between baseline and Week 26 3.Percentage of patients with HbA1c ââ?°Â¤6.5% at Week 26 4.Change in body mass index (BMI) between baseline and Week 26 | — |
Countries
Brazil, Canada, China, France, Germany, Hungary, India, Mexico, Saudi Arabia, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company (India) Pvt. Ltd
Outcome results
None listed