FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)

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.

Conditions

• Type 2 Diabetes

Interventions

DRUG

Insulin Glargine

Glargine-injectable, variable, once daily (QD), 6 months

DRUG

Metformin

Metformin-oral, up to 1000mg, twice daily (BID), 6 months

DRUG

Prandial insulin

Aspart or glulisine or lispro

DRUG

Exenatide

Injectable, 5mcg, twice daily (BID), 6 months

Sponsors & Collaborators

• Eli Lilly and Company

  collaborator INDUSTRY

• Sanofi

  collaborator INDUSTRY

• Astra Zeneca, Bristol-Myers Squibb

  collaborator OTHER

• DexCom, Inc.

  collaborator INDUSTRY

• Bayer

  collaborator INDUSTRY

• Becton, Dickinson and Company

  collaborator INDUSTRY

• Medicomp

  collaborator UNKNOWN

• University of Texas

  collaborator OTHER

• US Department of Veterans Affairs

  collaborator FED

• Biomedical Research Institute of New Mexico

  collaborator OTHER

• University of Washington

  lead OTHER

Principal Investigators

• Jeffrey L Probstfield, MD · Professor of Medicine, University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2014-07-31

Completion

2014-07-31

FDA Drug

Yes

Countries

• United States

Study Locations