Low dose/high dose Dapagliflozin for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Diabetes Mellitus, Type 2+1 More
Dapagliflozin - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is a study to see if two drugs are effective and safe for use in children and adolescents with type 2 diabetes.

Eligible Conditions
  • Diabetes Mellitus, Type 2

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Diabetes Mellitus, Type 2

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 52 weeks

26 weeks
Change from baseline in Fasting Plasma Glucose at Week 26
Change from baseline in HbA1c at Week 26
Percentage of subjects who require glycemic rescue medication or discontinue the study medication due to lack of efficacy during the 26-week treatment period
Percentage of subjects with baseline HbA1c ≥ 7%, who achieve an HbA1c level < 7.0% at Week 26
52 weeks
Change from baseline in FPG at Week 52
Change from baseline in HbA1c at Week 52
Percentage of subjects with baseline HbA1c ≥ 7% who achieve an HbA1c level < 7.0% at Week 52

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Diabetes Mellitus, Type 2

Trial Design

5 Treatment Groups

Low dose/high dose Dapagliflozin
1 of 5
Low dose Saxagliptin
1 of 5
Low dose Dapagliflozin
1 of 5
Low dose/high dose Saxagliptin
1 of 5
Placebo arm
1 of 5
Experimental Treatment
Non-Treatment Group

256 Total Participants · 5 Treatment Groups

Primary Treatment: Low dose/high dose Dapagliflozin · Has Placebo Group · Phase 3

Low dose/high dose Dapagliflozin
Drug
Experimental Group · 1 Intervention: Dapagliflozin · Intervention Types: Drug
Low dose Saxagliptin
Drug
Experimental Group · 1 Intervention: Saxagliptin · Intervention Types: Drug
Low dose Dapagliflozin
Drug
Experimental Group · 1 Intervention: Dapagliflozin · Intervention Types: Drug
Low dose/high dose Saxagliptin
Drug
Experimental Group · 1 Intervention: Saxagliptin · Intervention Types: Drug
Placebo arm
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
FDA approved
Saxagliptin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 52 weeks

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,956 Previous Clinical Trials
91,808,605 Total Patients Enrolled
339 Trials studying Diabetes Mellitus, Type 2
1,103,151 Patients Enrolled for Diabetes Mellitus, Type 2

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of childbearing potential and are willing to follow instructions for use of study drugs for the duration of treatment with study drugs.
You have previously been diagnosed with Type 2 Diabetes Mellitus by WHO/ADA criteria.
HbA1c between 6.5% and 10.5% obtained at screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.