Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00442767 |
Recruitment Status
:
Completed
First Posted
: March 2, 2007
Last Update Posted
: December 2, 2010
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal has been taken vs. standard therapy of pre-meal insulin on post-prandial glucose excursions.
The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes Mellitus | Drug: Pramlintide acetate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Reducing Postprandial Hyperglycemia With Adjuvant Premeal Pramlintide and Postmeal Insulin in Children With Type 1 Diabetes Mellitus. |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | February 2009 |

-
Drug: Pramlintide acetate
- Blood glucose level [ Time Frame: at the time of the study ]
- Insulin levels [ Time Frame: at the time of the study ]
- Glucagon levels [ Time Frame: at the time of the study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- type 1 diabetes only
- diagnosed with T1DM for at least 1 year
- HbA1C less than or equal to 8.5%
- currently treated using insulin glargine with or without Humalog/ Novolog OR on the insulin pump
- hemoglobin equal to or greater than 12mg/dL
- otherwise healthy, EXCEPT for T1DM and treated hypothyroidism
- negative pregnancy test, in the case of females
Exclusion Criteria:
- lack of supportive family
- evidence or history of chemical abuse
- BMI (body mass index) greater than the 90th percentile OR less than the 10th percentile for age
- patient who is poorly compliant with current insulin management and/or prescribed self blood glucose monitoring
- patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/ hospitalizations) in the past 6 months
- have hypoglycemia unawareness
- have a confirmed diagnosis of gastroparesis, and/ or require medications that stimulate gastrointestinal motility
- pregnant or lactating patients, or patients planning on becoming pregnant

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442767
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Rubina A Heptulla, MD | Baylor College of Medicine |
Responsible Party: | Rubina A Heptulla, MD, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00442767 History of Changes |
Other Study ID Numbers: |
H-18629 GCRC protocol #:0954 |
First Posted: | March 2, 2007 Key Record Dates |
Last Update Posted: | December 2, 2010 |
Last Verified: | November 2010 |
Keywords provided by Baylor College of Medicine:
pediatric juvenile diabetes mellitus Pediatric type 1 diabetes mellitus |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Pramlintide |
Insulin Islet Amyloid Polypeptide Hypoglycemic Agents Physiological Effects of Drugs Appetite Depressants Anti-Obesity Agents Amylin Receptor Agonists Molecular Mechanisms of Pharmacological Action |