DelfaGLP-1 Atlas

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CompletedPhase NA

Effect of Hyperglycemia on Gastric Emptying Interactions With Pramlintide

The Influence of Ambient Glycemia on the Effect of Pramlintide on Gastric Emptying in Patients With Type 1 Diabetes and Healthy Subjects

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

0

Recruiting sites

—

Enrollment

27

actual

Study population

Healthy volunteers, Type 1 diabetes

Key I/E criterion

•Healthy volunteers

Primary endpoint

•• To examine the influence of acute glycaemia on gastric emptying kinetics

Identifiers

Registered as

NCT IDNCT00489645
Org study IDPRAM025/04
Secondary IDDFG Schi 527/1-2

Timeline

Milestones

Study first posted2007-06-21estimated
Last update posted2008-01-16estimated
Study start2005-01 (month precision)
Primary completion2007-03actual (month precision)
Study completion2007-04actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Healthy volunteersType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the investigator grants an exception:

•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.
•20-40 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.

Exclusion criteria

•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:
•Any known structural gastrointestinal disorder,
•Gastrointestinal surgery except for appendectomy,
•Symptoms indicating functional or structural upper gastrointestinal disorder (pain, bloating, postprandial fullness, nausea, emesis,
•Gastroectomy, gastroparesis, lactose intolerance, and diseases known to alter small bowel absorption; e.g., inflammatory bowel disease.

CNS disease:

•Epilepsy (including subjects with a past history of convulsions associated with hypoglycaemia),
•Psychiatric illness (including history of eating disorder such as bulimia or anorexia).
•Autoimmune disease other than thyroid, pernicious anemia, or vitiligo.
•Malignant disease requiring chemotherapy,
•Any acute febrile illness within 2 weeks of Screening (Visit 1) with a temperature of 100°F,
•Currently abusing alcohol or drugs, or have a history of alcohol or drug abuse that in the investigator's opinion could cause the subject to be non-compliant; or have a general history of non-compliance with medications.
•Receipt of any investigational drug within 90 days of Screening (Visit 1) (prior treatment with pramlintide is permissible).
•Currently treated with medications known to interfere with gastric emptying such as, but not limited to:
–Ca2+ channel antagonists, ß-receptor antagonists, prokinetic agents metoclopramide (Reglan®) and cisapride (Propulsid®); and
–Chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives.
•Currently treated with:
–Bile acid sequestering resins cholestyramine (Questran®) and colestipol (Colestid®),
–Systemic steroids,
–Anti-obesity agents (including orlistat [Xenical®] and sibutramine [Meridia®]),
–Alpha-glucosidase inhibitors (acarbose [Precose®] and miglitol [Glyset®]) and meglitinides ([Prandin®] and [Starlix®]).

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
1
Other (unclassified)
1

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint/low confidence

• 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

Time frame:2 years

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

• 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.

Time frame:2 years

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.