Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Insulin Glargine 0.5 u/kg body wt · 1 trial · 1 indication
measuring the changes in glucose infusion rate during the 24 hour experimental period.
| Arm | Type | Description |
|---|---|---|
| Placebo then Insulin Glargine | EXPERIMENTAL | Placebo: administer single dose of Placebo subcutaneously (SC) with blood glucose monitoring over 24 hours. Then Insulin Glargine SQ 8 weeks later, in increasing doses (0.5, 1.0, 1.5, 2.0 u/kg body wt.) with blood glucose monitoring monitoring over a 24 hour period. Each dose is separated by 8 weeks (5 separate study visits) |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | single dose of Placebo injected s/c at 8am and monitor blood glucose over 24 hours |
| Insulin Glargine 0.5 u/kg body wt SC | DRUG | 8 weeks later, a differing dose (0.5, 1.0, 1.5, 2.0 u/kg body wt.) of Insulin Glargine and monitoring over a 24 hour period each separated by 8 weeks (5 separate study visits) |
| Insulin Glargine 1.0 u/kg body wt SC | DRUG | - |
| Insulin Glargine 1.5 u/kg body wt SC | DRUG | - |
| Insulin Glargine 2.0 u/kg body wt SC | DRUG | - |
Inclusion Criteria: * 12 adults (males or females) with type 2 diabetes for at least six (6) months. May be using oral agents (SUs, metformin, acarbose or glitinides) with or without insulin. * HgbA1c 7 -12% * Age 18-70 years * BMI 27-40 kg/m² Exclusion Criteria: * Any past or present clinically ...
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