Initiation of Insulin Aspart in Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00572806
• Date of registration: 12/12/2007
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Initiation of Insulin Aspart in Type 2 Diabetes
• Scientific title: Evaluation of the Initiation of Insulin Treatment Using Insulin Aspart on Blood Glucose Profile in Type 2 Diabetes Mellitus
• Date of first enrolment: February 5, 2003
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00572806
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type 2 diabetes for at least 3 years

- HbA1c greater than 8.0%

- Body Mass Index (BMI) below 40.0 kg/m2

- Inadequate treatment with diet and OADs

- Never received treatment with insulin

Exclusion Criteria:

- Type 1 diabetes

- Known or suspected allergy to investigational product



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Diabetes

Intervention(s)

Drug: insulin aspart

Primary Outcome(s)

Blood glucose value [Time Frame: at 5 pm in a daytime blood glucose cycle profile]

Secondary Outcome(s)

Evaluation of 24-hour blood glucose cycle

Hypoglycaemic episodes

HbA1c

Secondary ID(s)

ANA-1501

Source(s) of Monetary Support

Please refer to primary and secondary sponsors