Study to evaluate safety and efficacy of Dapagliflozin in patients with type 2 diabetes mellitus aged 10-24 years

Phase 1

• Conditions: Diabetes mellitus type 2; MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-005041-31-GB
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-01
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

- Provision of informed consent prior to any study-specific procedures
- Males and Females, ages 10 years of age, up to but not including 25 years of age at the time of randomization
- Previously diagnosed as having type 2 diabetes for at least 2 months by WHO/ADA diagnostic criteria
- HbA1c >= 6.5% and <= 11% obtained at screening visit
- Currently on diet and exercise and a stable dose of metformin (at least 1000 mg daily) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of metformin (at least 1000 mg daily) and insulin for a minimum of 8 weeks prior to screening
- FPG <= 255 mg/dL (<= 14.2 mmol/L) obtained at screening visit
Are the trial subjects under 18? yes
Number of subjects for this age range: 45
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Previous diagnosis of Type 1 diabetes
- Diabetes ketoacidosis (DKA) within 6 months of screening
- Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study:
*Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, oral or injectable incretins or incretin mimetics or other antidiabetes medications not otherwise specified
* Sixteen weeks: thiazolidinediones
* Any previous history or current use of an SGLT2 inhibitor, including dapagliflozin
- Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening. Use of prescription or non-prescription weight loss drugs must be stable
during the study
- Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding
- History of unstable or rapidly progressive renal disease
-History of unresolved vesico-ureteral reflux
- Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to the Day 1 visit
Note: Topical, nasal, or inhaled corticosteroids are allowed
- Abnormal renal function, which is defined in subjects < 18 years of age as an estimated glomerular filtration rate (eGFR) calculated by the Schwartz Formula < 80 mL/min/1.73 m2
(1.33 mL/s), and in subjects >= 18 years as an estimated glomerular filtration rate (eGFR) calculated by the MDRD Formula < 60 mL/min/1.73 m2 (1.33 mL/s)
- Presence of either: antibodies to glutamic acid decarboxylase (GAD) or protein tyrosine phosphatase-like protein antibodies (IA-2)
- An abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded
- Hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization
- Anemia of any etiology defined as hemoglobin <= 10.7 g/dL (107 g/L) for females and <= 11.3 g/dL (113 g/L) for males. Subjects who are considered to have anemia according to local guidelines should be excluded
- Volume-depleted subjects. Subjects at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics, should carefully monitor their volume status

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified