Dapagliflozin in Type 1 Diabetes

Glycemic Control Clinical Trial

— DapaT1DM  

Official title:

Short-term Effects of Dapagliflozin on Fasting and Postprandial Glucose Homeostasis in Male Type 1 Diabetes Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211742
• Other study ID #: CUI_001
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: February 8, 2017

Study information

• Verified date: March 2023
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dapagliflozin is a highly selective, reversible and potent inhibitor of the sodium-glucose-linked Transporter 2 (SGLT2), which was successfully investigated for its use as a treatment option in type 2 diabetes mellitus. The effect of dapagliflozin is an increased glucosuria, and it was shown that mean blood glucose concentrations and postprandial glucose excursion in special were significantly reduced in type 2 diabetic patients. Due to its mechanism-of action it seems likely that also type 1 diabetic patients will benefit from dapagliflozin. The present study is focused on the effects of dapagliflozin on fasting glucose homeostasis and postprandial glucose excursion in male type 1diabetic patients. Participants will subsequently receive 10 milligrams of dapagliflozin and placebo for 3 days (equals 2 x 30mg per cross-over period) in a double-blind, randomised, cross-over design. The effects will be measured via euglycemic hyperinsulinemic clamp studies (fasting glucose homeostasis) and euglycemic oral glucose tolerance clamp tests (postprandial glucose excursions).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 8, 2017
• Est. primary completion date: July 29, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus (duration of disease at least 5 years)

• C-peptide concentration < 0.2µg/l

• male sex

• aged 18 to 60 years

• Body Mass Index 20 - 25 kg/m2

• no measurable, clinically relevant ketonuria

Exclusion Criteria:

• insufficient venous status on both forearms

• renal and/or hepatic insufficiency (including microalbuminuria and/or albumin/creatinin-ratio)

• history of cancer

• intake of medication and/or substances capable to influence insulin sensitivity within the last 3 months prior to study inclusion

• alcohol- and/or drug abuse, nicotine consumption > 5 cigarettes / 24h

• brittle-diabetes

• history of severe hypoglycemia, defined as the need for foreign assistance independent of actual blood glucose concentration measured

• history or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the investigator may compromise the ability of the participant to give written informed consent, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Fasting Glucose
• Glucose Excursion
• Glycemic Control

Intervention

Drug:
• Dapagliflozin
euglycemic hyperinsulinemic clamp tests and euglycemic oral glucose tolerance clamp tests after the short-term (i.e.: 3 days, equals 10mg / 24h) intake of dapagliflozin

Locations

Country	Name	City	State
Austria	Medical University Innsbruck, Department of Internal Medicine I	Innsbruck	Tirol

Sponsors (3)

Lead Sponsor	Collaborator
Medical University Innsbruck	Medical University of Graz, University of Bern

Country where clinical trial is conducted

Austria, 

References & Publications (4)

Abdul-Ghani MA, DeFronzo RA. Dapagliflozin for the treatment of type 2 diabetes. Expert Opin Pharmacother. 2013 Aug;14(12):1695-703. doi: 10.1517/14656566.2013.812632. Epub 2013 Jun 26. — View Citation

DeFronzo RA, Hompesch M, Kasichayanula S, Liu X, Hong Y, Pfister M, Morrow LA, Leslie BR, Boulton DW, Ching A, LaCreta FP, Griffen SC. Characterization of renal glucose reabsorption in response to dapagliflozin in healthy subjects and subjects with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):3169-76. doi: 10.2337/dc13-0387. Epub 2013 Jun 4. — View Citation

Mather A, Pollock C. Glucose handling by the kidney. Kidney Int Suppl. 2011 Mar;(120):S1-6. doi: 10.1038/ki.2010.509. — View Citation

Plosker GL. Dapagliflozin: a review of its use in type 2 diabetes mellitus. Drugs. 2012 Dec 3;72(17):2289-312. doi: 10.2165/11209910-000000000-00000. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting glucose homeostasis	During hyperinsulinemic, euglycemic clamp studies, fasting glucose homeostasis will be determined for both, dapagliflozin and placebo.	study visit, immediatly
Primary	postprandial glucose homeostasis	During euglycemic oral glucose tolerance clamp tests, postprandial glucose excursion will be determined and compared between dapagliflozin and placebo.	study visit, immediatly