Coefficient of Variation at 26 Weeks Minus Coefficient of Variation at Baseline
| Group | Value (percentage) | Spread |
|---|---|---|
| Insulin Glargine, Metformin, Exenatide | -2.43 | 7.89 |
| Insulin Glargine, Metformin, Prandial Insulin | 0.44 | 5.50 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataShort name FLAT-SUGAR
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Insulin Glargine, metformin, exenatide
Approximately 60 Type 2 diabetes mellitus (DM) participants will be instructed on an American Heart Association/American Diabetes Association (AHA/ADA) meal plan. Insulin Glargine, metformin and exenatide will used as a combination strategy to control individual glycosylated hemoglobin level (HbA1Cs) between 6.7 and 7.3% throughout the trial. The use of exenatide makes this the intervention arm
Active comparator
glargine, metformin, prandial insulin
Approximately 60 type 2 DM participants will be instructed in AHA/ADA meal plan. Insulin Glargine, metformin and one of 3 prandial insulins will be used as combination strategy to control individual HbA1Cs between 6.7 and 7.3%. Prandial Insulins (aspart, glulisine or lispro). The use of the short acting insulins make this the control arm
Outcomes the sponsor listed as primary.
Coefficient of Variation at 26 Weeks Minus Coefficient of Variation at Baseline
Time frame · At baseline, 6 months of intervention
The change in the coefficient of variation (CV) of continuous glucose readings, as assessed by Continuous Glucose Monitoring (CGM)
Number of Participants With Hypoglycemia
Time frame · 26 weeks
Severe hypoglycemia-documented glucose \<50mg/dl (participant journal), and hypoglycemic attacks requiring hospitalization, or treatment by emergency personnel.
Weight Change During Trial
Time frame · Baseline vs 26 weeks
Weight in kg at 26 weeks minus weight at baseline.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage) | Spread |
|---|---|---|
| Insulin Glargine, Metformin, Exenatide | -2.43 | 7.89 |
| Insulin Glargine, Metformin, Prandial Insulin | 0.44 | 5.50 |
| Group | Value (Participants) |
|---|---|
| Insulin Glargine, Metformin, Exenatide | 0 |
| Insulin Glargine, Metformin, Prandial Insulin | 0 |
| Group | Value (kg) | Spread |
|---|---|---|
| Insulin Glargine, Metformin, Exenatide | -4.8 | 3.3 |
| Insulin Glargine, Metformin, Prandial Insulin | 0.7 | 3.3 |
| Group | Value (% of HbA1C) | Spread |
|---|---|---|
| Insulin Glargine, Metformin, Exenatide | 7.1 | 0.6 |
| Insulin Glargine, Metformin, Prandial Insulin | 7.2 | 0.6 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Insulin Glargine, Metformin, ExenatideDrug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Exenatide Injectable, 5mcg, BID, 6 months | 1 / 52 | 4 / 52 | 46 / 52 |
| Insulin Glargine, Metformin, Prandial InsulinDrug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Prandial insulin Aspart or glulisine or lispro | 0 / 50 | 5 / 50 | 37 / 50 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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