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Dapagliflozin Plus Pioglitazone in T1DM

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ClinicalTrials.gov Identifier: NCT03878459
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:

Purpose: To examine the effect of addition of combination therapy with dapagliflozin plus pioglitazone to insulin on glucose control and plasma ketone concentration in patients with type 1 diabetes (T1DM) Research Design: 120 patients with type 1 diabetes who otherwise are healthy constitute the study population. After screening, eligible subjects will start 4 week run in. At week 4, subjects will receive dapagliflozin for 12 weeks. At week 16, subjects will be randomized to receive in a double blind fashion pioglitazone or placebo for 16 weeks.

Methods: the following techniques will be employed in the present study: (1) mixed meal tolerance test; (2) indirect calorimetry; (3) continuous glucose monitoring.

Clinical Relevance: the results of the present study will demonstrate that the addition of pioglitazone to SGLT2 inhibitor in T1DM patients produces greater reduction in the HbA1c without increasing risk of ketoacidosis and hypoglycemia.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Pioglitazone 45 mg Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: placebo controlled intervention
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Can Addition of Pioglitazone to SGLT2 Inhibitor in Type 1 Diabetic Patients Amplify the Decrease in HbA1c and Prevent the Increase in Plasma Ketone Concentration?
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
pioglitazone treatment
Drug: Pioglitazone 45 mg
patients will be started on 15 mg and the dose escalated to the maximal tolerated dose

Placebo Comparator: control
subjects will receive placebo
Drug: Placebo
PATIENTS WILL RECEIVE PLACEBO




Primary Outcome Measures :
  1. Decrease in HbA1c [ Time Frame: 28 weeks ]

Secondary Outcome Measures :
  1. plasma ketones [ Time Frame: 28 weeks ]
    increase in plasma ketone concentration

  2. insulin dose [ Time Frame: 28 weeks ]
    decrease in daily insulin dose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • T1DM
  • Good general health
  • Fasting C-peptide concentration <0.7 ng/ml
  • Poor glycemic control (HbA1c=7.0-11.0%)
  • Treatment with multiple daily insulin injections or insulin pump
  • Total daily insulin dose ≥0.6 U/kg per day
  • Stable insulin dose (±4 units) in the preceding three months.
  • eGFR≥60 ml/min
  • Weight stable over the preceding 3 months (± 3 pounds)
  • Do not participate in an excessively heavy exercise program

Exclusion Criteria:

  • T2DM
  • Daily insulin dose <0.6 U/kg per day
  • Fasting C-peptide >0.7 ng/ml
  • HbA1c <7.0% or >11.0%
  • eGFR<60 ml/min
  • Hematuria in urine analysis
  • Pregnancy, lactating, positive pregnancy test or planning to become pregnant in the following year.
  • Women of child-bearing potential will be requested to use at least two barrier methods before being enrolled in the study.
  • Major organ system disease which includes: (i) malignancy or history of malignancy including bladder cancer; (ii) Congestive heart failure or history of coronary heart disease or any other cardiac disease; (iii) chronic liver disease or LFT >3 times the upper normal level; (iv) History of alcohol or drug abuse; (v) History of chronic lung disease (e.g., COPD, asthma); (vi) history of rheumatic disease; (vii) History of chronic pancreatitis or pancreatic surgery; (viii) History of CVA or TIA (ix) Planned surgery during the study; (x) history of HIV infection or other immune compromised disease; and history of organ transplantation; (xi) patients who take medications, other than insulin, known to affect glucose metabolism, e.g., prednisone.
  • Evidence of proliferative diabetic retinopathy
  • Patients enrolled in a heavy exercise program
  • Patients on ketogenic diet
  • History of hospitalization for DKA, hypoglycemia or uncontrolled hyperglycemia in the preceding 6 month.
  • Presence of symptoms of poor glycemic control, e.g. polydipsia or polyurea
  • History of hypersensitivity to dapagliflozin or pioglitazone

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): NCT03878459


Contacts
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Contact: Muhammad Abdul-Ghani, MD, PhD 210 567 2391 ABDULGHANI@UTHSCSA.EDU

Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03878459     History of Changes
Other Study ID Numbers: HSC20180515H
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Texas Health Science Center at San Antonio:
T1DM,ketoacidosis, dapagliflozin, pioglitazone
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pioglitazone
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action