Phase 2
N=45
Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers
Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT01128192 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Change in Insulin Basal Level — -24.37; -29.60 pmol/L — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pasireotide (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Robert R. Henry, MD
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insulin Basal Level |
-24.37; -29.60 | <0.001 sig |
| PRIMARY Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp |
-28.07; -27.95; -1450.59; -1474.65; -1478.65; -1502.60 | <0.001 sig |
| PRIMARY Change in Basal Endogenous Glucose Production (EGP) |
-0.041; 0.112 | 0.608 |
| PRIMARY Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition |
-7.54; -6.28 | 0.178 |
| PRIMARY Change in High Dose % Endogenous Glucose Production (EGP) Inhibition |
-2.06; 0.00 | 0.573 |
| PRIMARY Change in Low-Dose Glucose Disposal Rate (GDR) |
-0.029; 0.791 | 0.956 |
| PRIMARY Change in High-Dose Glucose Disposal Rate (GDR) |
0.004; -0.027 | 0.993 |
| SECONDARY Change in Fasting Plasma Glucose Level |
-0.10; 0.12 | 0.240 |
| SECONDARY Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT) |
-0.43; -0.86; 14.72; 12.35; 14.29; 11.49 | <0.001 sig |
| SECONDARY Change Fasting Plasma Insulin Level |
-6.62; -11.69 | 0.019 sig |
| SECONDARY Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT) |
-104.18; -100.90; -184.96; -262.15; -289.14; -363.06 | <0.001 sig |
Summary
This clinical study will attempt to find out why in early studies in healthy volunteers, injections under the skin of pasireotide were associated with temporary increases in both fasting and post-meal glucose levels, along with possible increases in insulin and glucagon levels. Glucose refers to the amount of sugar in your blood and insulin and glucagon levels are amounts of hormones that lower and raise blood sugar.
The purpose of the study is to evaluate the effects of pasireotide on insulin resistance and secretion. Insulin is a natural hormone made by the pancreas (a gland inside the abdomen) that controls the level of sugar in the blood. Insulin permits cells to use sugar for energy. Insulin resistance is the condition in which higher than normal amounts of insulin are necessary to allow the sugar to enter the cells. Insulin secretion refers to the amount of insulin produced by the body and released in the blood. Glucagon is a hormone (chemical substance produced by the pancreas gland in the body) which increases blood glucose.
Eligibility Criteria
Inclusion Criteria
- Lean, healthy, non-diabetic male.
Exclusion Criteria
- Family history of diabetes, BMI over 25.
Data sourced from ClinicalTrials.gov (NCT01128192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.