FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)
Public ClinicalTrials.gov record NCT01524705. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
FLAT-SUGAR: FLuctuATion Reduction With inSULin and Glp-1 Added togetheR
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Results of recent studies using standard long and short acting insulin therapy (Basal - Bolus or BBI) in type 2 diabetes mellitus (T2DM) have not shown benefits to lower risks for heart attacks, strokes, or eye, nerve and kidney problems. Some studies also show a long time between the start of treatment and signs of benefit. This has led to a review of current ways to normalize blood glucose control with basal bolus insulin and how to make blood glucose better. Improving blood sugar with insulin therapy usually causes weight gain, more high sugar levels after meals, and more low blood sugars. Early studies suggest that when people take long-acting insulin and metformin, they have fewer blood sugar extremes when they also take a new type of medicine called glucagon-like polypeptide-1 (GLP-1) agonist named exenatide (Byetta), instead of meal-time insulin. This means there might be a better way to treat Type 2 diabetes. Participants are asked to take part in an eight month study to find out if middle-aged and older people with Type 2 diabetes who have added risk factors for heart disease can even out their blood sugar levels. They will start on long-acting insulin, mealtime insulin, and metformin, if they are not already on these medications. Their kidney function tests must be normal and they must not be allergic to metformin. Then, after a 2 month run-in phase, they must be willing to be assigned by chance into one of two groups. This means that they will have a 50/50 chance (like flipping a coin) of being in either group. Half of them will be started on the new medicine known as Byetta rather than the meal-time insulin and the other half will remain on the meal-time insulin during the next 6 months (26 weeks) to see which group has more steady blood sugars. They will be asked to use a continuous blood sugar monitoring system called DexCom. A sensor is inserted under the skin in the same areas the insulin is injected. The DexCom can check their blood sugars 24 hours of the day and night and will be worn until 7 days of recordings are collected. In the same 7 day period, they will also be asked to wear a Holter or Telemetry monitor that will record their heart beats and rhythm which will be compared to the blood sugar readings. They will also use home glucose meters to check their glucose levels about 3 to 4 times a day. The study will take place at 12 centers in the United States and enroll about 120-130 people.
Study identification
- NCT ID
- NCT01524705
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 102 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2012
- Primary completion
- Jun 30, 2014
- Completion
- Jun 30, 2014
- Last update posted
- Dec 28, 2023
2012 – 2014
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| So Calif. Permanente Medical Group | San Diego | California | 92109 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Kaledia Health of Western New York | Buffalo | New York | 14209 | — |
| Diabetes Care Center | Durham | North Carolina | 27713 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| University of Vermont | Colchester | Vermont | 05446 | — |
| University of Washington | Seattle | Washington | 98105 | — |
| Washington State University Spokane, College of Pharmacy Spokane WA 99202 USA | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01524705, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 28, 2023 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01524705 live on ClinicalTrials.gov.