| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyperinsulinemic Hypoglycemia Postprandial Hypoglycemia | Drug: ZP4207 Other: Placebo (saline) | Phase 2 |
The Roux-En-Y gastric bypass (RYGB) has major health-promoting effects - reversing type-2-diabetes, improving dyslipidemia and inducing robust weight loss. However, several RYGB-individuals, post surgery, suffers from dumping syndrome and postprandial hyperinsulinemic hypoglycemia (PHH) due to the anatomical rearrangement of the gastro-intestinal system. Dasiglugaon (also known as (ZP4207) has shown great pharmacokinetic- and dynamic effects, compared to other glucagon analogues on the market, when administrated to hypoglycemic type-1-diabetics.
Therefore we aim to examine the effects of two different doses of dasiglucagon on the postprandial nadir plasma glucose concentration in RYGB-operated individuals suffering from PHH by use of a mixed meal test (MMT).
The study is designed as a double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days in which participants will undergo an MMT along with one of the following double-blinded interventions:
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 10 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | Double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass |
| Actual Study Start Date : | September 18, 2019 |
| Actual Primary Completion Date : | February 26, 2020 |
| Actual Study Completion Date : | February 26, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 80 ug of sc dasiglucagon
80 ug of dasiglucagon in a 0.4 mL fluid (saline) is injected abdominal subcutaneous postprandial prior to hypoglycemia.
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Drug: ZP4207
Abdominal SC administration
Other Name: Dasiglucagon
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Experimental: 200 ug of sc dasiglucagon
200 ug of dasiglucagon in a 0.4 mL fluid (saline) is injected abdominal subcutaneous postprandial prior to hypoglycemia.
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Drug: ZP4207
Abdominal SC administration
Other Name: Dasiglucagon
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Placebo Comparator: 0.4 mL of sc saline (placebo)
0.4 mL fluid (saline/placebo) is injected abdominal subcutaneous postprandial prior to hypoglycemia.
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Other: Placebo (saline)
Abdominal SC administration
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Denmark | |
| Center for Clinical Metabolic Research, Herlev-Gentofte Hospital | |
| Hellerup, Denmark, 2900 | |
| Principal Investigator: | Filip M. Knop, Prof., MD | Herlev-Gentofte Hospital, Center for Clinical Metabolic Research |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 6, 2019 | ||||
| First Posted Date ICMJE | June 13, 2019 | ||||
| Last Update Posted Date | March 31, 2020 | ||||
| Actual Study Start Date ICMJE | September 18, 2019 | ||||
| Actual Primary Completion Date | February 26, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Nadir plasma glucose concentration within two hundred forty minutes after MMT [ Time Frame: Two hundred forty minutes ] Nadir plasma glucose concentration within two hundred forty minutes after MMT
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass | ||||
| Official Title ICMJE | Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass | ||||
| Brief Summary | The aim of this study is investigating the effect of a novel glucagon analogue administration in gastric bypass operated individuals, who are reactive hypoglycemic. | ||||
| Detailed Description |
The Roux-En-Y gastric bypass (RYGB) has major health-promoting effects - reversing type-2-diabetes, improving dyslipidemia and inducing robust weight loss. However, several RYGB-individuals, post surgery, suffers from dumping syndrome and postprandial hyperinsulinemic hypoglycemia (PHH) due to the anatomical rearrangement of the gastro-intestinal system. Dasiglugaon (also known as (ZP4207) has shown great pharmacokinetic- and dynamic effects, compared to other glucagon analogues on the market, when administrated to hypoglycemic type-1-diabetics. Therefore we aim to examine the effects of two different doses of dasiglucagon on the postprandial nadir plasma glucose concentration in RYGB-operated individuals suffering from PHH by use of a mixed meal test (MMT). The study is designed as a double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days in which participants will undergo an MMT along with one of the following double-blinded interventions:
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days Masking: Double (Participant, Investigator)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
10 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | February 26, 2020 | ||||
| Actual Primary Completion Date | February 26, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Denmark | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03984370 | ||||
| Other Study ID Numbers ICMJE | CKN-DASI-RYGB 2019-001915-22 ( EudraCT Number ) |
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| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Filip Krag Knop, University Hospital, Gentofte, Copenhagen | ||||
| Study Sponsor ICMJE | University Hospital, Gentofte, Copenhagen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University Hospital, Gentofte, Copenhagen | ||||
| Verification Date | March 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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