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Clinical Trials/EUCTR2014-003313-28-DE
EUCTR2014-003313-28-DE
Active, not recruiting
Phase 1

SGLT2 inhibition with empagliflozin in patients with type 2 diabetes mellitus: Influences on left ventricular mass, function, and cardiac lipid content (EMPATROPHY) - Empagliflozin and left ventricular mass

Hannover Medical School0 sites60 target enrollmentJune 18, 2015
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ConditionsPatients with type 2 diabetes mellitus on background metformin treatment.MedDRA version: 18.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsJardiance® 25 mg FilmtablettenGlimepirid-ratiopharm® 2 mg Tabletten

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients with type 2 diabetes mellitus on background metformin treatment.
Sponsor
Hannover Medical School
Enrollment
60
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 18, 2015
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. women and men \= 40 and \< 80 years of age
  • •2\. patients with type 2 diabetes mellitus on stable anti\-diabetic treatment for the last 3 months; at screening the following treatment conditions are allowed:
  • •metformin \+ sulfonylurea with HbA1c \= 6\.5% and \= 9\.0%
  • •metformin monotherapy with HbA1c \= 7\.5% and \= 9\.0%
  • •metformin \+ DPP\-IV inhibitor withHbA1c \= 6\.5% and \= 9\.0%
  • •3\. waist circumference \= 80 cm in women or \= 94 cm in men
  • •4\. office blood pressure \= 150/95 mm Hg with a stable dose of a maximum of 4 antihypertensive medications for the last 3 months (24h ambulatory blood pressure measurement (ABPM) is allowed to check accuracy of office values; inclusion with 24h mean blood pressure \= 145/90 mm Hg is possible)
  • •5\. women without childbearing potential defined by:
  • •at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy
  • •hysterectomy

Exclusion Criteria

  • •1\. diabetes mellitus type 1
  • •2\. uncontrolled diabetes mellitus type 2 with fasting glucose \> 13\.3 mmol/l confirmed on a second day
  • •3\. previous treatment with insulin, GLP\-1 analogues, or pioglitazone during the last year before screening
  • •4\. previous participation in another empagliflozin trial
  • •5\. acute illness at screening or randomization according to judgement by the investigator or patient
  • •6\. known or suspected hypersensitivity to empagliflozin, glimepiride or any excipients; known or suspected hypersensitivity to sulfonylureas or sulfonamides
  • •7\. history of multiple severe hypoglycemic episodes
  • •8\. any condition prohibiting MRI studies (e.g. metal implants, claustrophobia, body weight too high)
  • •9\. patient akctively attempted to lose weight or experienced unintentional clinically significant weight loss during the last 3 months
  • •10\. bariatric surgery or other gastrointestinal surgery procedures that induce chronic malabsorption

Outcomes

Primary Outcomes

Not specified

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