Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs (1-2-3)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00791895
First received: November 13, 2008
Last updated: June 5, 2012
Last verified: June 2012
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Purpose
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal insulin therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: biphasic insulin aspart 30 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) Titrate-To-Target: An Observational Study of the Efficacy of NovoLog® Mix 70/30 in Patients With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets on OADs With / Without Once Daily Basal Insulin Therapy |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Percentage of subjects achieving HbA1c below 6.5% [ Time Frame: after 16, 32 and 48 weeks, respectively ] [ Designated as safety issue: No ]
| Enrollment: | 102 |
| Study Start Date: | June 2003 |
| Study Completion Date: | November 2004 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: biphasic insulin aspart 30
Treat-to-target dose titration scheme
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes mellitus for at least 12 months
- HbA1c: 7.5-10.0%
- An antidiabetic regimen that has been stable for at least 3 months
- Able and willing to perform SMBG testing as per protocol
Exclusion Criteria:
- Use of any insulin preparations other than NPH or glargine within the past 6 months
- Pregnancy, breastfeeding, intention to become pregnant within the next 12 months, or judged to be using inadequate contraceptive measures (adequate contraceptive measures includes: sterilization, intrauterine devices, oral contraceptives, or consistent use of barrier methods)
- Known or suspected allergy to trial product or agents related to trial product
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791895
Locations
| United States, Arizona | |
| Novo Nordisk Clinical Trial Call Center | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Novo Nordisk Clinical Trial Call Center | |
| La Jolla, California, United States, 92093-0831 | |
| Novo Nordisk Clinical Trial Call Center | |
| San Deigo, California, United States, 92103 | |
| United States, Florida | |
| Novo Nordisk Clinical Trial Call Center | |
| Deland, Florida, United States, 32720 | |
| United States, Nebraska | |
| Novo Nordisk Clinical Trial Call Center | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New York | |
| Novo Nordisk Clinical Trial Call Center | |
| Albany, New York, United States, 12206 | |
| United States, Ohio | |
| Novo Nordisk Clinical Trial Call Center | |
| Cleveland, Ohio, United States, 44115 | |
| United States, Oregon | |
| Novo Nordisk Clinical Trial Call Center | |
| Medford, Oregon, United States, 97504 | |
| United States, Tennessee | |
| Novo Nordisk Clinical Trial Call Center | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Novo Nordisk Clinical Trial Call Center | |
| Dallas, Texas, United States, 75231 | |
| Novo Nordisk Clinical Trial Call Center | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Novo Nordisk Clinical Trial Call Center | |
| Ogden, Utah, United States, 84403 | |
| United States, Washington | |
| Novo Nordisk Clinical Trial Call Center | |
| Renton, Washington, United States, 98057 | |
| United States, Wisconsin | |
| Novo Nordisk Clinical Trial Call Center | |
| Milwaukee, Wisconsin, United States, 53209 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Elizabeth Hillier | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00791895 History of Changes |
| Other Study ID Numbers: | BIASP-2174 |
| Study First Received: | November 13, 2008 |
| Last Updated: | June 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin aspart |
Insulin Insulin, NPH Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013