Diabetes Mellitus, Type 1Phase 2NCT00791076
The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients
A Phase 2 study testing Pancreatic Polypeptide (PP) in people with Diabetes Mellitus, Type 1, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is naturally produced by the pancreas and that works to control the amount of glucose that the liver makes, will reduce the amount of insulin required for people who must take insulin to maintain their normal blood glucose level. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Pancreatic Polypeptide (PP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Durations of type 1 Diabetes Melitis (DM) ≤ 8 years.
- Not currently on pump therapy.
- Type 1 DM who has a BMI ≥ 35.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 (Auto-immune) and Post-pancreatectomy Diabetic Patients
The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is naturally produced by the pancreas and that works to control the amount of glucose that the liver makes, will reduce the amount of insulin required for people who must take insulin to maintain their normal blood glucose level.
Read the detailed description
The pancreas is a large gland located behind the stomach. One of the functions of the pancreas is to produce two hormones: insulin and pancreatic polypeptide. Insulin helps the cells to take in glucose. The liver makes glucose and insulin normally acts to decrease or shut off the liver's production of glucose. However, in patients whose pancreas no longer makes insulin or makes low levels of pancreatic polypeptide the liver cannot perform these duties as well. Studies have shown that these important functions of the liver are improved for these patients when pancreatic polypeptide is given together with their insulin. Because PP increases the liver's sensitivity to insulin and thereby reduces the amount of glucose produced by the liver, this will result in fewer swings in blood sugar levels both in the upper and lower range. With fewer swings in blood glucose, a patient should decrease the amount of insulin used. One of the main benefits of lowering total insulin requirement is a reduction in the development of dangerous low blood sugar levels.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Placebo, Pancreatic Polypeptide (PP)
- Keywords
- Insulin pump therapy, Type 1 diabetic, Chronic pancreatitis, Pancreatic resection, Pancreatic polypeptide
- Medical subject headings
- Diabetes Mellitus, Type 1, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Saline
2pmol/kg-1/min-1 placebo infused continuously over 72 hours.
Pancreatic Polypeptide (PP)Drug
Also called PP
2pmol/kg-1/min-1 PP infused continuously over 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Saline Placebo | Placebo comparator | Saline Receives: Drug: Placebo |
| Pancreatic Polypeptide | Active comparator | Pancreatic Polypeptide Receives: Drug: Pancreatic Polypeptide (PP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Amount of Insulin Administered While on Placebo/PP.
Glucose values and the pattern of glycemic excursions over the 72 hour test period.
Measured: 2 years
Secondary outcomes (1)
Frequency of Hypoglycemia Defined as < 60 mg/dl.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: PI left JHU
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dariush Elahi, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791076
- Sponsor's protocol ID
- NA_00010957
- Status last verified
- Jun 2017
- First submitted
- 13 Nov 2008
- Last updated
- 12 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 (Auto-immune) and Post-pancreatectomy Diabetic Patients
- ClinicalTrials.gov ID
- NCT00791076
- Acronym / sponsor ID
- NA_00010957
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Insulin pump therapy, Type 1 diabetic, Chronic pancreatitis, Pancreatic resection, Pancreatic polypeptide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left JHU
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Oct 2007 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Posted 12 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is naturally produced by the pancreas and that works to control the amount of glucose that the liver makes, will reduce the amount of insulin required for people who must take insulin to maintain their normal blood glucose level.
Detailed description
The pancreas is a large gland located behind the stomach. One of the functions of the pancreas is to produce two hormones: insulin and pancreatic polypeptide. Insulin helps the cells to take in glucose. The liver makes glucose and insulin normally acts to decrease or shut off the liver's production of glucose. However, in patients whose pancreas no longer makes insulin or makes low levels of pancreatic polypeptide the liver cannot perform these duties as well. Studies have shown that these important functions of the liver are improved for these patients when pancreatic polypeptide is given together with their insulin. Because PP increases the liver's sensitivity to insulin and thereby reduces the amount of glucose produced by the liver, this will result in fewer swings in blood sugar levels both in the upper and lower range. With fewer swings in blood glucose, a patient should decrease the amount of insulin used. One of the main benefits of lowering total insulin requirement is a reduction in the development of dangerous low blood sugar levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline Placebo | Placebo comparator | Drug: PlaceboSaline |
| Pancreatic Polypeptide | Active comparator | Drug: Pancreatic Polypeptide (PP)Pancreatic Polypeptide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Saline2pmol/kg-1/min-1 placebo infused continuously over 72 hours. | Drug | Saline Placebo |
| Pancreatic Polypeptide (PP)Also: PP2pmol/kg-1/min-1 PP infused continuously over 72 hours. | Drug | Pancreatic Polypeptide |
Primary outcome
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.
1 secondary outcome
Frequency of Hypoglycemia Defined as < 60 mg/dl.
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dariush Elahi, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pancreatic Polypeptide (PP) in people with Diabetes Mellitus, Type 1, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Amount of Insulin Administered While on Placebo/PP. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.