Clinical Trials Logo
  1. Home
  2. Type II Diabetes Mellitus
  3. NCT01262586
  4. Details
NCT01262586 Clinical Trial

Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

Type II Diabetes Mellitus Clinical Trial

Official title:
Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01262586
Other study ID # CLAF237A23151
Secondary ID 2010-021236-34
Status Completed
Phase Phase 3
First received December 16, 2010
Last updated November 16, 2016
Start date November 2010
Est. completion date March 2011

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles between vildagliptin and glimepiride.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Type 2 diabetes patients on stable metformin

- 18-70 years old

- Willing to perform at least 4 capillary blood glucose tests per day

Exclusion Criteria:

- Type 2 diabetes patients on any other antidiabetic treatment

- Patients listed in other trials

- Patients with significant diabetic organ disease or complications.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin

• Glimepiride

Locations
Country Name City State
Germany Novartis Investigative Site Mainz

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

He YL, Foteinos G, Neelakantham S, Mattapalli D, Kulmatycki K, Forst T, Taylor A. Differential effects of vildagliptin and glimepiride on glucose fluctuations in patients with type 2 diabetes mellitus assessed using continuous glucose monitoring. Diabetes — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Glycemic profiles between vildagliptin and glimepiride Baseline and treatment Day 5, 24hr continuous glucose measurements No
Secondary Glucose Fluctuation before and during treatment Baseline and treatment Day 5, 24hr continuous measurements No
See also
  Status Clinical Trial Phase
Completed NCT01952535 - A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers Phase 1
Completed NCT01196728 - Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes Phase 1
Terminated NCT00997152 - Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients Phase 2
Completed NCT02592421 - SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2 Phase 3
Completed NCT05544214 - Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects Phase 1
Completed NCT01969084 - The Effect of Linagliptin on Mitochondrial and Endothelial Function Phase 4
Terminated NCT01644201 - A Study Evaluating the Effects of a High Viscosity Non-starch Polysaccharide (PolyGlycopleX® - PGX®) on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics Phase 3
Completed NCT01020123 - Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients Phase 2
Completed NCT00995787 - Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea Phase 1
Completed NCT01505426 - A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients Phase 3
Completed NCT00561171 - Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria Phase 2
Recruiting NCT03912363 - Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids N/A
Completed NCT01868646 - Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus Phase 4
Not yet recruiting NCT06386328 - A Clinical Trial to Evaluate the Food Effect of CKD-378 Phase 1
Terminated NCT02749435 - A Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus N/A
Completed NCT00894868 - Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure Phase 4
Recruiting NCT01165190 - Effect of Pioglitazone on Mitochondrial Function in Muscle and Adipose Tissue in Humans N/A
Completed NCT01255085 - Yellow Pea Protein and Fibre and Short Term Food Intake N/A
Completed NCT02156349 - A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients. N/A
Completed NCT03084965 - Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan

External Links