Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes

NCT00447382 | Completed Phase 3 Results

• 2 other identifiers: EX1729-17782006-004733-15
• Study Type: interventional
• Target: 330
• Locations: 5 countries
• Sites: 5

Brief Summary

The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks at the same total daily dose and frequency of administration as their own pre-trial basal insulin . During the trial doses were individualised based on subject's plasma glucose measurements.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies

  Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.

  week 0, week 52

Secondary Outcomes (23)

• Hypoglycaemic Episodes

  Weeks 0-52

• Glycaemic Control Parameters (Change in HbA1c)

  week 0, week 52

• Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])

  week 0, week 52

• Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])

  week 0, 26 and 52

• Change From Baseline in Detemir Specific Antibodies

  Week 0, week 52

Study Arms (2)

NN304

ACTIVE COMPARATOR

Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks

Drug: insulin detemir; Drug: insulin aspart

NN729

EXPERIMENTAL

Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks

Drug: insulin aspart; Drug: insulin detemir

Interventions

insulin detemir DRUG

NN304 injected s.c. (under the skin). Given as basal insulin.

NN304

insulin aspart DRUG

Injected s.c. (under the skin). Given as bolus insulin.

NN304; NN729

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes for at least 12 months
• Basal-bolus treatment for at least 3 months
• Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2
• HbA1c (glycosylated haemoglobin) less than or equal to 12.0%

You may not qualify if:

• Known or suspected allergy to trial products or related products
• Pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
• Receipt of any trial drug within 1 month prior to this trial
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
• Conditions that may interfere with trial participation as judged by Investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (5)

Unknown Facility

Frankfurt, 60590, Germany

Location

Unknown Facility

Skopje, 1000, North Macedonia

Location

Unknown Facility

Moscow, 119034, Russia

Location

Unknown Facility

Belgrade, 11000, Serbia and Montenegro

Location

Unknown Facility

Cape Town, Western Cape, 7925, South Africa

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Detemir; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 14, 2007
• Study Start: March 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 2, 2024
• Results First Posted: May 12, 2011

Record last verified: 2023-12

Locations

NO (1); ZA (1); SE (1); RU (1); DE (1)