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Clinical Trials/EUCTR2015-005740-34-DE
EUCTR2015-005740-34-DE
Active, Not Recruiting
Phase 1

Effectiveness of Dapagliflozin + Saxagliptin to revert from a standard basalbolusinsulin treatment (BBIT) regimen to a basal supported oral therapy(BOT) in patients with Type 2 Diabetes – a randomised double-blindedstudy – a randomised double-blinded study - Dapa-Saxa-BBIT

niversitätsklinikum Tübingen0 sites4 target enrollmentSeptember 29, 2016
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DrugsForxigaonglyzaActrapid

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversitätsklinikum Tübingen
Enrollment
4
Status
Active, Not Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 29, 2016
End Date
March 3, 2020
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversitätsklinikum Tübingen

Eligibility Criteria

Inclusion Criteria

  • •Type 2 diabetes
  • •Age 18 \- 75 years
  • •Anti\-GAD antibodies negative
  • •C\-peptide levels \= 1\.5 ng/mL
  • •Fasting blood glucose \= 126 mg/dl
  • •HbA1c 8\.0 – 10\.5 %
  • •BMI 25\.0 – 45\.0 kg/m2
  • •Previous therapy with standard BBIT (basal insulin and at least
  • •once daily bolus insulin) when the bolus insulin dose is not adjusted
  • •to exercise or nutrient intake.

Exclusion Criteria

  • •Use of any oral antidiabetic treatment except for metformin (i.e.,
  • •sulphonylureas, DPP\-IV inhibitors, thiazolidinediones, SGLT\-2
  • •inhibitors) or GLP\-1 analogues within the last three months prior to
  • •Repeated episodes of severe hypoglycaemia within the last six
  • •months prior to Screening
  • •History of diabetic ketoacidosis, praecoma diabeticum, or diabetic
  • •Treatment with any other investigational drug within the last three
  • •months before Screening
  • •Acute infections within the last four weeks prior to Screening
  • •Recurrent urogenital infections

Outcomes

Primary Outcomes

Not specified

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