Primary outcomeMean· -30 min and -15 min on Day 2 and Day 9
Change in Insulin Basal Level
| Group | Value (pmol/L) | Spread |
|---|---|---|
| Pasireotide 600 µg sc Bid | -24.37 | 10.42 |
| Pasireotide 900 µg sc Bid | -29.60 | 16.05 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataSomatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers
Short name Pasireotide
NCTNCT01128192 (opens ClinicalTrials.gov in a new tab)Other idSOM230Novartis/VMRF
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 45 participants (actual)
- Sponsor
- Robert R. Henry, MD · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Aug 2009
- Primary completion
- Apr 2010
- Completion
- Apr 2010
- First posted
- 21 May 2010 (estimated)
- Last update posted
- 25 Dec 2014 (estimated)
- Conditions
- Hyperglycemia
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200920102011
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- pasireotideDrug
Arms3
Experimental
Pasireotide 600 µg sc bid
n=19. Pasireotide 600 µg sc bid
Experimental
Pasireotide 900 µg sc bid
n=19. Pasireotide 900 µg sc bid
Experimental
Pasireotide 1200 µg sc bid
n=7. Due to increased severity of gastro-intestinal side effects, this arm was discontinued. These participants were only included in the safety analysis.
Primary outcomes7
Outcomes the sponsor listed as primary.
Change in Insulin Basal Level
Time frame · -30 min and -15 min on Day 2 and Day 9
Registry description
Change from Day 2 and Day 9 of insulin basal levels (2-step hyperglycemic clamp test with arginine stimulation)
Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp
Time frame · 0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9)
Registry description
Blood samples were taken at -30 min, -15 min, 0 min, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min, 165 min, 180 min to assess the plasma insulin levels during Hyperglycemic Clamp (2-step hyperglycemic clamp test with arginine stimulation). The mean change in plasma insulin levels from Day 2 to Day 9 were calculated as Values on Day 9 - Values on Day 2.
Change in Basal Endogenous Glucose Production (EGP)
Time frame · Day 3 and Day 10
Registry description
Change from Day 3 and Day 10 of Basal EGP (Hyperinsulinemic-Euglycemic Clamp)
Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition
Time frame · Day 3 and Day 10
Registry description
Change from Day 3 and Day 10 of low dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)
Change in High Dose % Endogenous Glucose Production (EGP) Inhibition
Time frame · Day 3 and Day 10
Registry description
Change from Day 3 and Day 10 of high dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)
Change in Low-Dose Glucose Disposal Rate (GDR)
Time frame · Day 3 and Day 10
Registry description
Change from Day 3 and Day 10 in Low-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.
Change in High-Dose Glucose Disposal Rate (GDR)
Time frame · Day 3 and Day 10
Registry description
Change from Day 3 and Day 10 in High-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.
Secondary outcomes(4)
Change in Fasting Plasma Glucose Level
Time frame · -30 minutes on Day 1 and -30 minutes on Day 8
Registry description
An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma glucose level. The mean change in fasting plasma glucose level from Day 1 to Day 8 was assessed.
Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)
Time frame · 0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)
Registry description
Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma glucose level. The mean change in plasma glucose level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1.
Change Fasting Plasma Insulin Level
Time frame · -30 minutes on Day 1 and -30 minutes on Day 8
Registry description
An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma insulin level. The mean change in fasting plasma insulin level from Day 1 to Day 8 was assessed.
Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)
Time frame · 0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)
Registry description
Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma insulin level. The mean change in plasma insulin level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· 0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9)
Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp
| Group | Value (h*pmol/L) | Spread |
|---|---|---|
| Pasireotide 600 µg sc Bid | -28.07 | 19.15 |
| Pasireotide 900 µg sc Bid | -27.95 | 18.56 |
Primary outcomeMean· Day 3 and Day 10
Change in Basal Endogenous Glucose Production (EGP)
| Group | Value (mg/kg/min) | Spread |
|---|---|---|
| Pasireotide 600 µg sc Bid | -0.041 | 0.342 |
| Pasireotide 900 µg sc Bid | 0.112 | 0.308 |
Primary outcomeMean· Day 3 and Day 10
Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition
| Group | Value (percentage of EGP Inhibition) | Spread |
|---|---|---|
| Pasireotide 600 µg sc Bid | -7.54 | 23.47 |
| Pasireotide 900 µg sc Bid | -6.28 | 16.31 |
Secondary and other outcome results(4)
Secondary outcomeMean· -30 minutes on Day 1 and -30 minutes on Day 8
Change in Fasting Plasma Glucose Level
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Pasireotide 600 µg sc Bid | -0.10 | 0.36 |
| Pasireotide 900 µg sc Bid | 0.12 | 0.50 |
Secondary outcomeMean· 0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)
Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)
| Group | Value (h*mmol/L) | Spread |
|---|---|---|
| Pasireotide 600 µg sc Bid | -0.43 | 0.43 |
| Pasireotide 900 µg sc Bid | -0.86 | 0.45 |
Secondary outcomeMean· -30 minutes on Day 1 and -30 minutes on Day 8
Change Fasting Plasma Insulin Level
| Group | Value (pmol/L) | Spread |
|---|---|---|
| Pasireotide 600 µg sc Bid | -6.62 | 11.17 |
| Pasireotide 900 µg sc Bid | -11.69 | 10.96 |
Secondary outcomeMean· 0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)
Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)
| Group | Value (h*pmol/L) | Spread |
|---|---|---|
| Pasireotide 600 µg sc Bid | -104.18 | 90.60 |
| Pasireotide 900 µg sc Bid | -100.90 | 68.99 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Pasireotide 600 μg sc BidForty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only. | – | 0 / 19 | 18 / 19 |
| Pasireotide 900 μg sc BidForty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only. | – | 0 / 19 | 18 / 19 |
| Pasireotide 1200 μg sc BidForty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only. | – | 0 / 7 | 7 / 7 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2013
11 results
Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers.
Henry et al. 2013The Journal of clinical endocrinology and metabolismcited by 200
PMID 23733372DOI 10.1210/jc.2013-1771PUB-23733372
Full text at the publisher11 results
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years up to 50 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Lean, healthy, non-diabetic male.
Exclusion Criteria:
* Family history of diabetes, BMI over 25.
PepBank is a research reference. Talk to a doctor before you use any peptide.