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Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2

Intervention: biphasic insulin aspart 30 (Drug); biphasic insulin aspart 30 (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

Summary

This trial is conducted in Africa and Asia. The aim of the trial is to compare patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in type 2 diabetes patients uncontrolled on NPH insulin.

Clinical Details

Official title: A 20-week Study Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients Uncontrolled on NPH Insulin

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in HbA1c from baseline

Secondary outcome:

Change in fasting plasma glucose (FPG) (laboratory values) from baseline

Number of hypoglycaemic episodes during the trial from baseline

Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosed with type 2 diabetes for a minimum of 12 months prior to screening

- Currently treated with a NPH insulin for at least 3 months prior to screening

- Stable treatment (no change in dose or regimen) with a total daily dose of at least

1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The metformin treatment must have been stable for at least 2 months prior to screening

- HbA1c between 7. 0% and 10. 0% (both inclusive). (One re-test within one week of

screening visit is allowed. The last sample will be conclusive.)

- Body Mass Index (BMI) below or equal to 40. 0 kg/m^2

- Able and willing to eat at least 2 main meals each day during the trial

- Able and willing to adhere to the protocol including compliance with performance of

self measured plasma glucose (SMPG), injection regimen and titrating themselves according to the protocol

- Experience in performing self measured plasma glucose (SMPG)

Exclusion Criteria:

- Treatment with any thiazolidinedione (TZD) and Glucagon-like peptide-1 (GLP-1)

receptor agonists or pramlintide within the last 3 months prior to screening

- Impaired hepatic function defined as alanine aminotransferase (ALAT) above or equal

to 2. 5 times upper referenced limit. (One re-test within one week of screening visit is allowed. The last sample will be conclusive.)

- Impaired kidney function with serum creatinine above or equal to 133 µmol/L (1. 5

mg/dL) for males and above or equal to 124 µmol/L (1. 4 mg/dL) for females. (One re-test within one week of screening visit is allowed. The last sample will be conclusive.)

- Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as

systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)

- Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed

human preparations)

- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the

last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months

- Known proliferative retinopathy or maculopathy requiring treatment

Locations and Contacts

Beni-Suef 62511, Egypt

Malang 65111, Indonesia

Rabat 10000, Morocco

Jeddah 80215, Saudi Arabia

Tunis 1008, Tunisia

Ho Chi Minh City, Vietnam

Additional Information

Clinical Trials at Novo Nordisk

Starting date: May 2012
Last updated: July 15, 2015

Page last updated: August 23, 2015

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