Type 2 DiabetesNCT00732147
Effects of Pramlintide on Endogenous Production of Very-low-density-lipoprotein (VLDL)-Triglyceride and Glucose in the Post Prandial State in T2DM
A study testing Pramlintide acetate in people with Type 2 Diabetes, run by University of Maryland, Baltimore.
Trial summary
Diabetes affects almost 21 million people in the United States. In this study we will test a drug called Pramlintide(Symlin), and see how it works to lower blood sugar and fat levels after a meal. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Pramlintide acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Type 2 DM study participants will be C-Peptide positive (levels > 0.3 nmol/L)
- Receiving insulin, metformin and/or sulfonylurea/glitinide.
- Maintained on stable anti-hypertensive medication.
- BMI < 52 kg/m2.
- T2DM for at least 3 months with HBA1C under 10%.
Who cannot join
- Receiving TZDs, exenatide, sitagliptin or pramlintide therapy.
- Receiving medications known to impair gastric emptying, intestinal motility, glucagon release or corticosteroids.
- Triglyceride levels > 400 mg/dl.
- BMI > 52 kg/m2.
About this study
Official title: Effects of Pramlintide on Endogenous Production of VLDL-Triglyceride and Glucose in the Post Prandial State in Type 2 Diabetes Mellitus
Diabetes affects almost 21 million people in the United States. In this study we will test a drug called Pramlintide(Symlin), and see how it works to lower blood sugar and fat levels after a meal. Lowering high sugar levels and fat levels after a meal is very important in the prevention of the problems that persons with type 2 diabetes often encounter. Hypothesis is that Pramlintide will lower blood sugar and fat levels after a meal.
Read the detailed description
A well recognized and troublesome feature of diabetes management is the exacerbated post prandial glucose elevations following a typical high fat meal. To date the mechanisms driving this increased post prandial glycemia are unclear. Pramlintide is believed to affect intermediary metabolism as well as nutrient absorption. The relative contributions from altered absorption and metabolism to the observed post prandial reductions in plasma glucose and TG concentrations remain uncertain, however. Combinations of radioactive and stable isotope labeling techniques are able to quantify the relevant fluxes of glucose and lipids in vivo in humans and are therefore able to provide quantitative answers to these questions.
Aims:
- To determine the effects of Pramlintide on reducing endogenous production of very-low-density-lipoprotein (VLDL)-triglycerides(TG) following a high fat breakfast, lunch and dinner in patients with type 2 diabetes mellitus (T2DM). A triple isotope approach will be used to determine rate of appearance of (VLDL)-triglycerides following breakfast, lunch and dinner.
- To compare the relative roles of slowed glucose absorption and reduced endogenous glucose production (glucagonstatic mechanism) in the glucose-lowering effects of Pramlintide in the post prandial state in patients with T2DM.
- Conditions
- Type 2 Diabetes
- Being tested
- Pramlintide acetate, Placebo
- Keywords
- triglycerides, endogenous, glucose, production
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramlintide acetateDrug
Also called Symlin
120 micrograms given subcutaneously before each meal X 3.
PlaceboDrug
120 micrograms given subcutaneously before each meal x 3.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Type 2 diabetes patients will receive placebo with 3 meals in experimental period. Receives: Drug: Placebo |
| 1 | Experimental | Type 2 Diabetes patient will receive Pramlintide with 3 meals in experimental period. Receives: Drug: Pramlintide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous glucose production
Measured: 18 hours
Secondary outcomes (1)
Endogenous VLDL-Triglyceride production
Measured: 18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Sponsor could not fund.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Responsible party
- Principal investigator, Stephen N. Davis, MBBS, University of Maryland, Baltimore
- Investigators
- Stephen N. Davis, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732147
- Sponsor's protocol ID
- hp-00044094
- Status last verified
- Jul 2021
- First submitted
- 6 Aug 2008
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pramlintide on Endogenous Production of VLDL-Triglyceride and Glucose in the Post Prandial State in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00732147
- Acronym / sponsor ID
- hp-00044094
- Conditions
- Type 2 Diabetes
- Keywords
- triglycerides, endogenous, glucose, production
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor could not fund.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes affects almost 21 million people in the United States. In this study we will test a drug called Pramlintide(Symlin), and see how it works to lower blood sugar and fat levels after a meal. Lowering high sugar levels and fat levels after a meal is very important in the prevention of the problems that persons with type 2 diabetes often encounter. Hypothesis is that Pramlintide will lower blood sugar and fat levels after a meal.
Detailed description
A well recognized and troublesome feature of diabetes management is the exacerbated post prandial glucose elevations following a typical high fat meal. To date the mechanisms driving this increased post prandial glycemia are unclear. Pramlintide is believed to affect intermediary metabolism as well as nutrient absorption. The relative contributions from altered absorption and metabolism to the observed post prandial reductions in plasma glucose and TG concentrations remain uncertain, however. Combinations of radioactive and stable isotope labeling techniques are able to quantify the relevant fluxes of glucose and lipids in vivo in humans and are therefore able to provide quantitative answers to these questions.
Aims:
- To determine the effects of Pramlintide on reducing endogenous production of very-low-density-lipoprotein (VLDL)-triglycerides(TG) following a high fat breakfast, lunch and dinner in patients with type 2 diabetes mellitus (T2DM). A triple isotope approach will be used to determine rate of appearance of (VLDL)-triglycerides following breakfast, lunch and dinner.
- To compare the relative roles of slowed glucose absorption and reduced endogenous glucose production (glucagonstatic mechanism) in the glucose-lowering effects of Pramlintide in the post prandial state in patients with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: PlaceboType 2 diabetes patients will receive placebo with 3 meals in experimental period. |
| 1 | Experimental | Drug: Pramlintide acetateType 2 Diabetes patient will receive Pramlintide with 3 meals in experimental period. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Type 2 DM study participants will be C-Peptide positive (levels > 0.3 nmol/L)
- Receiving insulin, metformin and/or sulfonylurea/glitinide.
- Maintained on stable anti-hypertensive medication.
- BMI < 52 kg/m2.
- T2DM for at least 3 months with HBA1C under 10%.
Key exclusion criteria (4 listed)
- Receiving TZDs, exenatide, sitagliptin or pramlintide therapy.
- Receiving medications known to impair gastric emptying, intestinal motility, glucagon release or corticosteroids.
- Triglyceride levels > 400 mg/dl.
- BMI > 52 kg/m2.
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 |
|---|---|---|
| Pramlintide acetateAlso: Symlin120 micrograms given subcutaneously before each meal X 3. | Drug | 1 |
| Placebo120 micrograms given subcutaneously before each meal x 3. | Drug | 2 |
Primary outcome
Endogenous glucose production
Time frame: 18 hours
1 secondary outcome
Endogenous VLDL-Triglyceride production
Time frame: 18 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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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.
Stephen N. Davis, MD principal investigator
Vanderbilt University
Questions about this trial
What is this clinical trial studying?
A study testing Pramlintide acetate in people with Type 2 Diabetes, run by University of Maryland, Baltimore.
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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Endogenous glucose production (time frame: 18 hours). 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 22 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.