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NCT01524705 · ClinicalTrials.gov registry record · Phase 4
FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)
A Phase 4 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 102
- Enrollment target
NCT01524705: Completed Phase 4 study, sponsored by University of Washington.
NCT01524705 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 102 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01524705, a Phase 4 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 102 participants
- Enrollment target
Study Summary
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
Primary Outcome
The change in the coefficient of variation (CV) of continuous glucose readings, as assessed by Continuous Glucose Monitoring (CGM)
Interventions
- DRUG Metformin
- DRUG Exenatide
- DRUG Insulin Glargine
- DRUG Prandial insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
What the finished NCT01524705 record still lists
NCT01524705 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.
NCT01524705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01524705 about?
NCT01524705 is a clinical study titled "FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)". 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 treat...
What is the current status of trial NCT01524705?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2012-08. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01524705?
The interventions under investigation include: Metformin (DRUG), Exenatide (DRUG), Insulin Glargine (DRUG), Prandial insulin (DRUG).
Who is sponsoring clinical trial NCT01524705?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01524705's enrollment target sits among peer trials
102 764th of 2000 higher than 1,235 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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