Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years

Type 2 Diabetes Clinical Trial

Official title:

A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial With a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients Aged 10-24 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725593
• Other study ID #: D1690C00017
• Secondary ID: 2015-005041-31
• Status: Completed
• Phase: Phase 3
• Start date: June 22, 2016
• Est. completion date: April 6, 2020

Study information

• Verified date: January 2022
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the comparative efficacy and safety between dapagliflozin and Placebo.

Description:

A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial with a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients aged 10-24 years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 6, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 24 Years

Eligibility

Inclusion Criteria

1. Provision of informed consent prior to any study-specific procedures

2. Males and Females, ages 10 years of age, up to but not including 25 years of age at the time of randomization

3. Previously diagnosed as having type 2 diabetes for at least 2 months by WHO/ADA diagnostic criteria

4. HbA1c >= 6.5% and <= 11% obtained at screening visit

5. 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

6. FPG <=255 mg/dL (<= 14.2 mmol/L) obtained at screening visit

Exclusion Criteria:

1. Previous diagnosis of Type 1 diabetes

2. Diabetes ketoacidosis (DKA) within 6 months of screening

3. 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, 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

4. 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

5. Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding

6. History of unstable or rapidly progressive renal disease

7. History of unresolved vesico-ureteral reflux

8. 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

9. 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)

10. Presence of either: antibodies to glutamic acid decarboxylase (GAD) or protein tyrosine phosphatase-like protein antibodies (IA-2)

11. An abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded

12. Hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization

13. 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

14. 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Dapagliflozin
Dapagliflozin 10 mg tablets administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily, for the 28-week site and subject blinded long term extension.
• Dapagliflozin placebo
matching placebo tablets, administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily,for the 28-week site and subject blinded long term extension.

Locations

Country	Name	City	State
Hungary	Research Site	Budapest
Hungary	Research Site	Nyíregyháza
Israel	Research Site	Beer Sheva
Israel	Research Site	Haifa
Israel	Research Site	Jerusalem
Israel	Research Site	Ramat Gan
Israel	Research Site	Zerifin
Mexico	Research Site	Culiacan
Mexico	Research Site	Guadalajara
Mexico	Research Site	Merida
Mexico	Research Site	México, D.F.
Mexico	Research Site	Monterrey
Mexico	Research Site	Zapopan
Romania	Research Site	Oradea
Romania	Research Site	Timisoara
Russian Federation	Research Site	Izhevsk
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Pyatigorsk
Russian Federation	Research Site	Rostov-on-Don
Russian Federation	Research Site	Samara
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	Tomsk
United Kingdom	Research Site	Kent
United Kingdom	Research Site	Leicester
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bronx	New York
United States	Research Site	Buffalo	New York
United States	Research Site	Columbus	Ohio
United States	Research Site	Gainesville	Florida
United States	Research Site	Greenville	South Carolina
United States	Research Site	Homestead	Florida
United States	Research Site	Lampasas	Texas
United States	Research Site	McAllen	Texas
United States	Research Site	Memphis	Tennessee
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	New Haven	Connecticut
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
AstraZeneca	Covance Laboratories, Inc, Parexel, PRA Health Sciences, Q2 Solutions

Countries where clinical trial is conducted

United States,  Hungary,  Israel,  Mexico,  Romania,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24		Baseline to Week 24
Secondary	Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24		Baseline to Week 24
Secondary	Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control		Baseline to Week 24
Secondary	Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24		Baseline to Week 24

External Links

•   D1690C00017_CSP_redacted
•   D1690C00017_SAP_redacted