Status:
WITHDRAWN
Liraglutide Actions on the Liver: Effects on Glucose Phosphorylation
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Type 2 diabetes is a chronic disease that has reached epidemic proportions. In order to improve our strategies for preventing and treating type 2 diabetes the investigators need to better understand t...
Detailed Description
It is known that liraglutide impacts favorably glucose homeostasis in type 2 diabetic patients, but not the exact mechanism of this effect. In particular, liraglutide's acute and chronic effects on th...
Eligibility Criteria
Inclusion
- 18- 65 years of age (inclusive)
- Ability to provide informed consent before any trial-related activities
- Ability to communicate effectively with research staff
- Ability to return for follow up visit
- Adequate IV access
- If a female of childbearing potential, non-pregnant and taking reliable contraception
- Documented T2DM (per most recent American Diabetes Association criteria);
- Drug naïve or treated with metformin only;
- Diabetes should be well controlled (as defined by HbA1 ≤ 7.5%, FPG \<180 mg/dl).
Exclusion
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
- Presence of cancer or any clinically significant cardiac, respiratory, renal, hepatic, gastrointestinal, endocrinological, haematological, neurological, or psychiatric diseases or disorders (inclusion will be discussed with attending physician)
- Liver disease; history of alcoholism.
- Known or suspected allergy to liraglutide
- Contraindications to liraglutide: patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
- Patients with a history of pancreatitits
- Patients that have been treated with drugs that promote weight loss (e.g., Xenical® \[orlistat\], Meridia® \[sibutramine\], Acomplia® \[rimonabant\], Acutrim® \[phenylpropanolamine\], or similar over-the-counter medications) within 3 months of study start
- Patients that have been treated with diabetes drugs: injectables, (e.g GLP-1R agonists (Byetta® \[exenatide\], Victoza® \[liraglutide\]) amylin analogues; insulin and insulin analogues) or oral agents other than metformin (e.g.DPP-IV- inhibitors (Januvia® \[sitagliptin\], Onglyza® \[saxagliptin\] or Janumet® \[sitagliptin and metformin\]),insulin sensitizers (thiazolidindiones: pioglitazone \[Actos®\]); or sulfonylureas) within 3 months of study start.
- The receipt of any investigational drug within 3 months prior to study start.
- Type 1 diabetes
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02198209
Start Date
December 1 2019
End Date
December 1 2020
Last Update
September 30 2019
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048