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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK024092 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).
Participants: 64 T2D subjects with the same inclusion and exclusion criteria as Protocol 1. Subjects with hematuria are excluded.
Study Design: Infusions of 3-3H-glucose and 14C-glycerol are started and continued to study end (2 PM). Baseline blood samples for HbA1c (x2) and for plasma insulin, glucagon, glucose, FFA, BHB, AcAc, glycerol, and plasma 3-3H-glucose and 14C-glycerol specific activities are drawn at -30, -20, -10, -5, and 0 minutes for measurement of lipolysis, ketone production (plasma ketone levels), and EGP. Empagliflozin (25 mg) is ingested at time zero (9AM) and plasma samples for the above are obtained every 10-20 minutes.
Following completion of the above study, subjects will be randomized to one of four groups (16 per group) for 10 weeks: (1) empagliflozin, 25 mg/day, plus pioglitazone placebo; (2) pioglitazone, 15 mg/day, increased to 30 mg after 2 weeks plus empagliflozin placebo; (3) empagliflozin (25 mg/d) plus pioglitazone (15/30 mg/d); (4) empa placebo plus pio placebo. Subjects will return to the CRC every 1-2 weeks for interim medical history, to check medication compliance, and to measure plasma insulin, glucagon, glucose, FFA, glycerol, BHB, and AcAc levels. At week 10, subjects will return to the CRC at 6AM and the baseline study will be repeated. HbA1c will be measured twice during week 10.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin plus Pioglitazone placebo | Experimental | Empagliflozin 25 mg/day plus pioglitazone placebo |
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| Pioglitazone plus Empagliflozin Placebo | Placebo Comparator | Pioglitazone, 15 mg/day, increased to 30 mg after 2 weeks plus empagliflozin placebo |
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| Empagliflozin plus Pioglitazone | Experimental | Empagliflozin(25mg/day) plus pioglitazone (15/30 mg/d) |
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| Empagliflozin placebo + pioglitazone placebo | Experimental | empagliflozin placebo plus pioglitazone placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 MG plus Pioglitazone placebo | Drug | A medication used in the management and treatment of type 2 diabetes mellitus. It is in the sodium-glucose co-transporter (SGLT-2) class of medications. |
| Measure | Description | Time Frame |
|---|---|---|
| Endogenous Glucose Production (EGP) | Measurement of Endogenous Glucose Production (EGP) using stable isotope (6,6, D2- glucose infusion). | 0 and 300 minutes |
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Patients with T2D
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ralph DeFronzo, MD | Contact | 210-567-6691 | defronzo@uthscsa.edu | |
| Aurora Merovci, MD | Contact | 210-567-6691 | merovci@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ralph DeFronzo, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Diabetes Institute/UH | Recruiting | San Antonio | Texas | 78229-3900 | United States |
Deidentified data will be shared with NIH and as a publication in a peer reviewed journal once data are published.
At study end after analysis of data.
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A randomized controlled 4 arm clinical trial
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Subjects will be randomly assigned 1:1:1:1 ratio
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| Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo | Drug | Placebo-Inert tablet |
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| Empagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d) | Drug | Pioglitazone, a medication used in the management and treatment of type 2 diabetes mellitus. It is in the thiazolidinedione class of medications |
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| Pioglitazone placebo + Empagliflozin placebo | Drug | Placebo-Inert tablet |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000077205 | Pioglitazone |
| D051297 | Sodium-Glucose Transporter 2 |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D051247 | Sodium-Glucose Transport Proteins |
| D027981 | Symporters |
| D016623 | Ion Pumps |
| D026901 | Membrane Transport Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009004 | Monosaccharide Transport Proteins |
| D000070590 | Solute Carrier Proteins |
| D008565 | Membrane Proteins |
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