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Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

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ClinicalTrials.gov Identifier: NCT02401880
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH

Brief Summary:

The primary aim of this exploratory mechanistic study is to investigate the effects of Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients.

This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Linagliptin Other: Placebo Drug: Empagliflozin Phase 4

Detailed Description:

This study will be performed as a multi-center study which includes 2 centres. 44 subjects with T2DM are to be included according to the defined in- and exclusion criteria.

Subjects has to be on a stable metformin therapy and will receive in a first step empagliflozin for 30 days. Both therapies (metformin and empagliflozin) will be continued for another 30 days and subjects will be randomized to receive in addition Linagliptin or Placebo for 30 days.

Subjects will come for two inhouse periods to their corresponding study center and will undergo an hyperglycaemic clamp test as well as a Meal test in each of the periods.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology and Metabolic Control in Patients With Type 2 Diabetes Mellitus on Stable Metformin Treatment
Study Start Date : May 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Empagliflozin plus Linagliptin
Linagliptin 5mg to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
Drug: Linagliptin
22 subjects will receive Linagliptin for 30 days
Other Name: Trajenta

Drug: Empagliflozin
44 subjects will receive Empagliflozin for 60 days
Other Name: Jardiance

Placebo Comparator: Empagliflozin plus Placebo
Placebo to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
Other: Placebo
22 subjects will receive Placebo for 30 days

Drug: Empagliflozin
44 subjects will receive Empagliflozin for 60 days
Other Name: Jardiance

Empagliflozin
Empagliflozin 25mg will be adminstered for 30 days in T2DM patients
Drug: Empagliflozin
44 subjects will receive Empagliflozin for 60 days
Other Name: Jardiance




Primary Outcome Measures :
  1. • Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo) [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. • Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3) [ Time Frame: 30 days ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subject with diabetes mellitus type 2
  2. Diabetes mellitus type 2 on stable treatment with metformin (daily dose at least 1000 mg) for at least 6 months
  3. HbA1c 7.0%-9.9%, both inclusive
  4. Diabetes duration of at least 24 months)

Exclusion Criteria:

  1. History of diabetes mellitus type 1
  2. GFR (as calculated by the Cockcroft-Gault equation) < 60 ml/min at Screening
  3. Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg at Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401880


Locations
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Germany
Profil Mainz GmbH & Co. KG
Mainz, Germany, 55116
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH

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Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT02401880     History of Changes
Other Study ID Numbers: EMLIN-001
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Empagliflozin
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors