NCT00489645

Brief Summary

• To examine the influence of acute glycaemia (normoglycaemia and hyperglycaemia) on gastric emptying kinetics in patients with type 1 diabetes and non diabetic subjects when treated with subcutaneous (SC) injections of pramlintide.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
Last Updated

January 16, 2008

Status Verified

January 1, 2008

Enrollment Period

2.2 years

First QC Date

June 19, 2007

Last Update Submit

January 15, 2008

Conditions

Type 1 Diabetes

Keywords

pramlintidegastric emptyingT1DMpostprandial

Outcome Measures

Primary Outcomes (1)

  • • To examine the influence of acute glycaemia (normoglycaemia and hyperglycaemia) on gastric emptying kinetics in patients with type 1 diabetes and non diabetic subjects when treated with subcutaneous (SC) injections of pramlintide.

    2 years

Secondary Outcomes (1)

  • • Gastric peristalsis derived from high-resolution scintigraphy by means of Fast Fourier Transform (FFT) analysis. • Effects on gastric emptying and on the rate of appearance of ingested glucose appearance, postprandial glucose sequestration, endoge

    2 years

Study Arms (4)

1

PLACEBO COMPARATOR

Placebo, euglycemia

Drug: placebo

2

EXPERIMENTAL

Pramlintide, euglycemia

Drug: pramlintide

3

PLACEBO COMPARATOR

placebo, hyperglycemia

Drug: placebo

4

EXPERIMENTAL

pramlintide, hyperglycemia

Drug: pramlintide

Interventions

placeboDRUG

placebo SC during euglycemia

1
pramlintideDRUG

pramlintide SC during eglycemia

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of type 1 diabetes (otherwise healthy) with an HbA1 ≤ 9%, and on a stable insulin treatment for at least 3 months (preferably on pump regimen) prior to screening OR is a healthy individual.
  • years of age, inclusive.
  • Understand and sign an informed consent document, communicate with the investigator, and understand and comply with the requirements of the study.
  • Euthyroid, including subjects receiving thyroid replacement therapy.
  • If female:
  • Is surgically sterilized by hysterectomy; OR
  • Is post-menopausal, as documented by a history of amenorrhea for 6 months and follicle stimulating hormone (FSH) level within the range specified as post-menopausal by the reporting laboratory at screen (post menopausal women on estrogen may enter the study without obtaining an FSH level); OR
  • If of childbearing potential, meets the following criteria:
  • negative pregnancy test (ß-HCG), regardless of birth control method (including subjects with tubal ligation);
  • Practicing and willing to continue throughout the study the appropriate contraception (defined as oral, injected, or implanted contraceptives for at least 3 months prior to entry, or barrier contraception).
  • Agree to take every precaution to ensure that pregnancy will not occur during the study.

You may not qualify if:

  • Individuals meeting any of the following criteria are to be excluded from the study unless the investigator grants an exception:
  • History of severe hypoglycemia.
  • Body mass index (BMI) ≥ 30 kg/m2.
  • Autonomic nerve dysfunction: abnormal result in the cardiovascular parasympathetic and/or sympathetic tests (screening visit).
  • Hepatic disease:
  • Known hepatic disease or transaminases (GOT, GPT) ≥ 2x above normal values.
  • Renal disease:
  • Known or serum urea, serum creatinine ≥ 1.5x above normal values
  • Cardiovascular or pulmonary disease:
  • Arterial hypertension
  • Blood pressure \>150/95 mmHg at screening in a sitting position)
  • Arterial occlusive disease
  • Known coronary heart disease
  • Abnormal ECG at screening visit.
  • Gastrointestinal disease:
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

pramlintide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Joerg Schirra, MD

    Ludwig-Maximilians-University of Munic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 21, 2007

Study Start

January 1, 2005

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

January 16, 2008

Record last verified: 2008-01