FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Washington
Collaborators:
Astra Zeneca, Bristol-Myers Squibb Bayer Becton, Dickinson and Company Biomedical Research Institute of New Mexico Bristol-Myers-Squibb/Astra-Zeneca DexCom, Inc. Eli Lilly and Company Medicomp Sanofi University of Texas US Department of Veterans Affairs VA Office of Research and Development