NCT02426541: DERISC

Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus

Completed Phase 4 Results posted Last updated 5 February 2018

What this trial tests

Phase 4 trial testing Dapagliflozin in Type 2 Diabetes Mellitus in 55 participants. Completed in 28 April 2016.

Timeline

23 March 2015

Primary endpoint
28 April 2016

28 April 2016

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	55
Start date	23 March 2015
Primary completion	28 April 2016
Estimated completion	28 April 2016
Sites	1 location across Finland

Drugs / interventions tested

• Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
• Placebo

Conditions studied

• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 35 to 70, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adjusted Change in Adipose Tissue Insulin-stimulated Glucose Uptake Secondary · Baseline to Week 8

Change in adipose tissue insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET

Group	Value	95% CI
Dapagliflozin 10 MG	1.04	± 1.50
Placebo	-0.64	± 1.36

Adjusted Change in Liver Insulin-stimulated Glucose Uptake From Baseline to Week 8 Secondary · Baseline to Week 8

Adjusted change in liver insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET

Group	Value	95% CI
Dapagliflozin 10 MG	0.27	± 1.74
Placebo	1.59	± 1.52

Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake Primary · From baseline to Week 8

Adjusted change from baseline in skeletal muscle insulin-stimulated gluocose uptake (umol/min/kg)

Group	Value	95% CI
Dapagliflozin 10 MG	0.28	± 1.23
Placebo	0.28	± 1.13

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dapagliflozin 10 MG

Serious: 0/16 (0%)

Deaths: —

Placebo

Serious: 0/16 (0%)

Deaths: —

Other adverse events (15 terms — click to expand)

Reaction	System	Dapagliflozin 10 MG	Placebo
Polyuria	Renal and urinary disorders	—	—
Respiratory tract infection	Infections and infestations	—	—
Balanitis candida	Infections and infestations	—	—
Constipation	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Astenia	General disorders	—	—
Thirst	General disorders	—	—
Blood glucose decreased	Investigations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Joint swelling	Musculoskeletal and connective tissue disorders	—	—
Orthostatic hypotension	Vascular disorders	—	—
Headache	Nervous system disorders	—	—
Hypoaesthesia	Nervous system disorders	—	—
Presyncope	Nervous system disorders	—	—
Sinusitis	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT02426541 adverse events section.

Sponsor's own description

This is an 8-week, single centre, randomized, parallel-group, double-blind, placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific insulin sensitivity in patients with Type 2 diabetes mellitus

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trends in insulin resistance: insights into mechanisms and therapeutic strategy.
   Li M, Chi X, Wang Y, Setrerrahmane S, et al · · 2022 · cited 515× · PMID 35794109 · DOI 10.1038/s41392-022-01073-0
2. The crucial role and mechanism of insulin resistance in metabolic disease.
   Zhao X, An X, Yang C, Sun W, et al · · 2023 · cited 268× · PMID 37056675 · DOI 10.3389/fendo.2023.1149239
3. 53 <sup>rd</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : Lisbon, Portugal, 11 - 15 September 2017.
   · 2017 · cited 17× · PMID 28795195 · DOI 10.1007/s00125-017-4350-z
4. Unlocking the power of empagliflozin: Rescuing inflammation in hyperglycaemia-exposed human cardiomyocytes through comprehensive multi-level analysis.
   Benedetti R, Chianese U, Papulino C, Scisciola L, et al · · 2025 · cited 5× · PMID 39809551 · DOI 10.1002/ejhf.3566