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GlucoNorm

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Trials Updated: Jan 18, 2018

GlucoNorm development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

GlucoNorm clinical trials

GlucoNorm · 1 trial · 1 indication

Phase 2 1
NCT00451620Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 DiabetesType 2 Diabetes
COMPLETED30 Analytics
PHASE2COMPLETED
Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

The objective of this study is to determine whether GlucoNorm has a greater effect than Glyburide on insulin levels and postprandial glucose levels in elderly people with type 2 diabetes who are diet controlled.
2 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
2.EXPERIMENTALGlucoNorm
1.EXPERIMENTALGlyburide

Interventions

NameTypeDescription
glyburideDRUGSubjects will undergo 2 Standard Meal Tests with Ensure 325 ml separated by 15 - 30 days. Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 2.5 mg during the 2nd Standard Meal Test. Group 2 will receive Glyburide 2.5 mg during the 1st Standard Meal Test and GlucoNorm 1mg during the 2nd Standard Meal Test.
GlucoNormDRUGSubjects will undergo 2 Standard Meal Tests with Ensure 325 ml separated by 15 - 30 days. Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 2.5 mg during the 2nd Standard Meal Test. Group 2 will receive Glyburide 2.5 mg during the 1st Standard Meal Test and GlucoNorm 1mg during the 2nd Standard Meal Test.
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 2 diabetes \> 3 months duration * Male or female * Over 65 years of age * Diet controlled only * HgbA1C \< 8.5% Exclusion Criteria: * Treatment with oral hypoglycemic agents or insulin or the likelihood of requiring treatment with these during the study. * Anemia - hgb ...

Countries:Canada
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Frequently asked questions about GlucoNorm

What is GlucoNorm used for?

GlucoNorm is being studied for the treatment of Type 2 Diabetes. It is an investigational small molecule developed by Novo Nordisk A/S. The clinical program has focused on elderly patients with Type 2 Diabetes, specifically evaluating effects on post-prandial hyperglycemia, which is elevated blood sugar after meals.

Who makes GlucoNorm?

GlucoNorm is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program for this investigational small molecule in Type 2 Diabetes.

What phase is GlucoNorm in?

GlucoNorm is in Phase 2 clinical development. It has not been approved by the FDA and remains an investigational therapy for Type 2 Diabetes. The Phase 2 program includes one completed trial, and no active trials are currently listed for this asset.

What clinical trials is GlucoNorm in?

GlucoNorm has been evaluated in one completed Phase 2 trial, NCT00451620, titled Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes. The trial enrolled 30 participants in Canada, was randomized and controlled, and included subjects aged 65 years and older.

How was the GlucoNorm trial designed?

The GlucoNorm Phase 2 trial NCT00451620 was a randomized, controlled study comparing GlucoNorm with glyburide in elderly subjects with Type 2 Diabetes. It enrolled 30 participants aged 65 years and older in Canada and assessed post-prandial hyperglycemia. The study was completed and was not double-blind.