The Impact of Food on Blood Sugar in People With Type 2 Diabetes (REACT2)

This study has been completed.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
Sanofi
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01237314
First received: November 5, 2010
Last updated: October 9, 2013
Last verified: April 2013

November 5, 2010
October 9, 2013
November 2010
May 2013   (final data collection date for primary outcome measure)
4-hour glycemic response at 3 time points [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
The four-hour glycemic response includes: four-hour post-meal area under the median interstitial glucose curve, post-meal interstitial glucose peak, time to peak, time to return to pre-prandial level (to within 10% of baseline with a maximum of the 4-hour post-meal fast), difference between peak and baseline, average rate of change in interstitial glucose across the 4 hour post-meal period, and percent of the 4-hour post-meal glucose readings >180 mg/dL.
Same as current
Complete list of historical versions of study NCT01237314 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Impact of Food on Blood Sugar in People With Type 2 Diabetes
Evaluation of the Glycemic Impact of Food in Patients With Type 2 Diabetes Taking Glargine and/or Exenatide

This study will record the impact of food on blood glucose levels using continuous glucose monitoring (CGM).

The investigators think the impact will improve as medication doses are adjusted. The investigators also think that the impact will differ depending on the type of medication taken.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Participants in Clinical Trials Study NCT01089569

Type 2 Diabetes
Not Provided
  • Glargine Group
    After baseline titration of metformin, this group will take glargine along with metformin.
  • Exenatide Group
    After baseline titration of metformin, this group will take exenatide along with metformin.
  • Glargine and Exenatide Group
    After baseline titration of metformin, this group will take glargine and exenatide along with metformin.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Study participants who are consented for the primary study and have not yet done the baseline CGM data collection at week -2-0.

Exclusion Criteria:

  • Study participants who are unable to complete the baseline CGM data collection at week -2-0.
  • Study participants who are allergic to or have a food intolerance to any of the foods in the fixed meal
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01237314
04037-10-C
No
Park Nicollet Institute
Park Nicollet Institute
  • International Diabetes Center at Park Nicollet
  • Sanofi
Principal Investigator: Maggie Powers, PhD International Diabetes Center at Park Nicollet
Principal Investigator: Alice Shapiro, PhD International Diabetes Center at Park Nicollet
Park Nicollet Institute
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP