The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients
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ClinicalTrials.gov Identifier: NCT00791076 |
Recruitment Status
:
Terminated
(PI left JHU)
First Posted
: November 14, 2008
Results First Posted
: July 12, 2017
Last Update Posted
: July 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 1 | Drug: Placebo Drug: Pancreatic Polypeptide (PP) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 (Auto-immune) and Post-pancreatectomy Diabetic Patients |
Actual Study Start Date : | October 2007 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Saline Placebo
Saline
|
Drug: Placebo
2pmol/kg-1/min-1 placebo infused continuously over 72 hours.
Other Name: Saline
|
Active Comparator: Pancreatic Polypeptide
Pancreatic Polypeptide
|
Drug: Pancreatic Polypeptide (PP)
2pmol/kg-1/min-1 PP infused continuously over 72 hours.
Other Name: PP
|
- Total Amount of Insulin Administered While on Placebo/PP. [ Time Frame: 2 years ]Glucose values and the pattern of glycemic excursions over the 72 hour test period.
- Frequency of Hypoglycemia Defined as < 60 mg/dl. [ Time Frame: 72 hours ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female volunteers between the ages of 18-75 with:
- 10 subjects who are status post pancreatic resection and 10 volunteers who are Type 1 diabetic for > 8 years (volunteers must have a stable glycemic profile that includes use of an insulin pump to control their blood glucose) with or without prior pancreatic resection.
- HbA1c levels ≤ 8.5.
Exclusion Criteria:
- Lactating or pregnant females.
- Brittle or Labile diabetics: Volunteers with extremely erratic patterns of glucose control with large fluctuations in glucose levels for no obvious reason.
- Allergy to beef or beef by-products.
- Hypoglycemia within the past year requiring medical or other assistance to correct.
- Known autonomic neuropathy.
- Documented blood glucose under 60 mg within the past year and hypoglycemic unawareness.
- Durations of type 1 Diabetes Melitis (DM) ≤ 8 years.
- Not currently on pump therapy.
- Type 1 DM who has a BMI ≥ 35.

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): NCT00791076
United States, Maryland | |
Johns Hopkins Bayview Medical Center | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Dariush Elahi, PhD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00791076 History of Changes |
Other Study ID Numbers: |
NA_00010957 |
First Posted: | November 14, 2008 Key Record Dates |
Results First Posted: | July 12, 2017 |
Last Update Posted: | July 12, 2017 |
Last Verified: | June 2017 |
Keywords provided by Johns Hopkins University:
Insulin pump therapy Type 1 diabetic Chronic pancreatitis Pancreatic resection Pancreatic polypeptide |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin Pancreatic Polypeptide Hypoglycemic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |