Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery
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ClinicalTrials.gov Identifier: NCT03514576 |
Recruitment Status : Unknown
Verified July 2018 by Caroline Christfort Øhrstrøm, Zealand University Hospital.
Recruitment status was: Enrolling by invitation
First Posted : May 2, 2018
Last Update Posted : July 5, 2018
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Postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe complication of Roux-en-Y gastric bypass (RYGB), and the treatment options are limited. Pasireotide has shown to be effective in preventing hypoglycemia in RYGB operated subjects, however treatment often leads to increased hyperglycemia.
The purpose of this study is to investigate two doses of pasireotide that are lower than doses previously used in RYGB operated subjects with postprandial hyperinsulinemic hypoglycemia.
Condition or disease | Intervention/treatment | Phase |
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Hypoglycemia, Reactive | Drug: Pasireotide 0.3 MG/ML Diagnostic Test: Meal tolerance test (MTT) | Phase 4 |
With the growing number of RYGB operated subjects the attention on complications such as postprandial hyperinsulinemic hypoglycemia (PHH) has increased. PHH is characterized by increased glycemic variability and hypoglycemic episodes occurring 2-3 hours after a meal together with a markedly increase in insulin and glucagon-like-peptide 1 (GLP-1) levels. Symptoms vary from dizziness and palpitations to confusion, loss of consciousness and convulsions. At present there are few treatment options available for RYGB patients with PHH and most of them rely on dietary changes that are difficult to adhere to.
Pasireotide has been shown to reduce hypoglycemia in RYGB operated subjects with PHH, but often leads to increased hyperglycemia as well.
The purpose of the study is to investigate two doses of pasireotide in RYGB operated subjects with PHH.
Each subject will undergo two meal tolerance test (MTT) preceded by either 75 µg or 150 µg of pasireotide. Blood samples will be collected throughout the meal test at predefined time points and will be analyzed for glucose, insulin, C-peptide, GLP-1 and glucagon levels.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 5 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery |
Actual Study Start Date : | June 1, 2018 |
Estimated Primary Completion Date : | August 1, 2018 |
Estimated Study Completion Date : | November 1, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Pasireotide75
75 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)
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Drug: Pasireotide 0.3 MG/ML
See arm description
Other Name: Signifor Diagnostic Test: Meal tolerance test (MTT) Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling. |
Experimental: Pasireotide150
150 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)
|
Drug: Pasireotide 0.3 MG/ML
See arm description
Other Name: Signifor Diagnostic Test: Meal tolerance test (MTT) Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling. |
- Changes in glucose (mmol/L) in response to a meal tolerance test (MTT) [ Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion ]Changes in incremental area under the curve (iAUC) for glucose, nadir glucose values, peak glucose values, time spent with glucose values in the hyperglycemic (>7.8 mmol/L) and the hypoglycemic (<3.9 mmol/L) range
- Heart rate [ Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion ]Changes heart rate (beats/min) during the course of a meal tolerance test (MTT)
- Serum insulin levels [ Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion ]Changes in insulin (pmol/L) in response to a meal tolerance test (MTT)
- Serum C-peptide levels [ Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion ]Changes in C-peptide (nmol/L) in response to a meal tolerance test (MTT)
- Plasma glucagon levels [ Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion ]Changes in glucagon (pmol/L) in response to a meal tolerance test (MTT)
- Plasma GLP-1 levels [ Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion ]Changes in glucagon-like peptide 1 (pmol/L) in response to a meal tolerance test (MTT)
- Blood pressure [ Time Frame: From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion ]Changes in blood pressure (mmHg) in response to a meal tolerance test (MTT)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- RYGB operated patients with documented hypoglycemia (blood glucose <3.9 mmol/L) who have previously completed the study 'Treatment of hypoglycemia following gastric bypass surgery' (HypoGB2015)
- Hemoglobin > 7,3 mmol/L
- Negative human chorionic gonadotropin (hCG) urine test
- Females of reproductive age: use of safe contraception
Exclusion Criteria:
- Treatment for cardiovascular disease
- Treatment with antipsychotic medication
- Treatment for thyroid disease
- Prior medical treatment of postprandial hyperinsulinemic hypoglycemia
- Prior allergic reactions to the study medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514576
Denmark | |
Zealand University Hospital | |
Køge, Denmark, 4600 |
Principal Investigator: | Caroline C Øhrstrøm, MD | Department of Medicine, Zealand University Hospital |
Responsible Party: | Caroline Christfort Øhrstrøm, MD, ph.d. student, Zealand University Hospital |
ClinicalTrials.gov Identifier: | NCT03514576 |
Other Study ID Numbers: |
PasHypo |
First Posted: | May 2, 2018 Key Record Dates |
Last Update Posted: | July 5, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
gastric bypass hypoglycemia hyperinsulinemia |
Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases Pasireotide |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |