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Adult enteral formula

Phase 3

Diabetes Mellitus Type 2 | Unknown | Metabolic |Abbott Laboratories|Last Updated: Oct 15, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Adult enteral formula · 1 trial · 1 indication

Phase 3 1
NCT00540488Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional FormulasDiabetes Mellitus Type 2
COMPLETED54 Analytics
PHASE3COMPLETED
Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas
Diabetes Mellitus Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Adjusted area under the curve (adj-AUC) of glucose response
0-240 minutes

Secondary Endpoints

Adjusted peak for glucose and insulin response;peak time for glucose and insulin response; Adj-AUC for insulin response; change in glucose and insulin; subjective gastrointestinal tolerance
0 - 240 minutes
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Adult enteral formulaOTHER -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * signed and dated informed consent * 18-75 years of age * history of type 2 diabetes * males and non-pregnant, non-lactating females Exclusion Criteria: * subject uses insulin for glucose control * significant cardiovascular event \<12 weeks prior to study entry * active mali...

Countries:United States
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Frequently asked questions about Adult enteral formula

What is Adult enteral formula used for in Diabetes Mellitus Type 2?

Adult enteral formula is a nutritional product being studied for use in Diabetes Mellitus Type 2. It is designed to be consumed by adults with this condition, and a clinical trial has evaluated glucose and insulin responses after consuming diabetes-specific versus standard nutritional formulas.

Who makes Adult enteral formula?

Adult enteral formula is developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker ABT. The company is conducting clinical research to evaluate the formula's effects in people with Type 2 diabetes.

What phase is Adult enteral formula in?

Adult enteral formula is in Phase 3 clinical development. It is an investigational product, meaning it has not been approved by regulatory authorities. One Phase 3 trial has been completed to assess its effects in patients with Type 2 diabetes.

What clinical trials is Adult enteral formula in?

Adult enteral formula has been studied in one completed Phase 3 trial, NCT00540488, titled 'Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas'. The trial enrolled 54 participants in the United States and was randomized and double-blind.

Is Adult enteral formula the same as a standard nutritional formula?

Adult enteral formula is a diabetes-specific nutritional formula, distinct from standard nutritional formulas. A clinical trial compared glucose and insulin responses in subjects with Type 2 diabetes consuming diabetes-specific versus standard formulas, indicating the two are different products.