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NCT00042601·Phase 2·INTERVENTIONAL

Evaluation of the Effect of Pramlintide on Satiety and Food Intake

PramlintideOtherCompleted

Status

Completed

Phase

Phase 2

Enrollment

51

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.

Interventions

Treatment arms and agents.

DRUG

Pramlintide acetate

Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.

DRUG

Placebo

placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper

Timeline

From registration to results.

  1. First posted

    Aug 5, 2002

  2. Study start

    Jul 2002

  3. Primary completion

    Oct 2003

  4. Study completion

    Oct 2003

  5. Results posted

    Not reported

  6. Registry updated

    Oct 21, 2015

Outcomes

What the study measures.

Primary outcomes

Change in satiety of participants on Pramlintide

Time frame · 2 Weeks

To assess the acute effect of pramlintide administered subcutaneously (SC) on satiety in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes. To be measured by Total caloric intake, macronutrient intake (carbohydrate, fat, protein, and other), duration of buffet meal, aand satiety data measured via a satiety assessment at Period 1 (Visit 2) and Period 2 (Visit 3).

Change in food intake of participants on Pramlintide

Time frame · 2 Weeks

To assess the acute effect of pramlintide administered SC on food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes. To be measured by Total caloric intake, macronutrient intake (carbohydrate, fat, protein, and other), duration of buffet meal, aand satiety data measured via a satiety assessment at Period 1 (Visit 2) and Period 2 (Visit 3).

Secondary outcomes

Effect of pramlintide on postprandial metabolic and hormonal responses

Time frame · 2 Weeks

To assess the acute effect of pramlintide administered SC on postprandial metabolic and hormonal responses \[glucose, triglycerides, total cholesterol, insulin, cholecystokinin (CCK), and glucagon-like peptide (GLP-1)\] in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes. To be measured by the calculation of both absolute and incremental plasma analyte concentration profiles.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
MALE
Healthy volunteers
No

For Healthy Volunteers: •BMI \>=20 to \<=25kg/m2 or \>=30 to \<=40 kg/m2 For Subjects with Type 1 or Type 2 Diabetes: * Treated with insulin for at least 6 months prior to screening * HbA1c value between 6.5-10% inclusive * BMI between 20-40kg/m2

Study locations

1 registered sites.

Australia. Showing up to 24 locations stored in the fast local snapshot.

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsPramlintide trial dashboard →