NovoLet® Surveillance Study on Using Human Insulin System... | NCT01492153

Studies
NovoLet® Surveillance Study on Using Human Insulin System in Indonesia

NCT01492153

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 28, 2017Actual

Enrollment

1,981Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Interventions

biphasic human insulin
isophane human insulin
human soluble insulin

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2003Actual

Primary Completion Date

Sep 5, 2006Actual

Completion Date

Sep 5, 2006Actual

First Submitted Date

Dec 12, 2011

First Submission Date that Met QC Criteria

Dec 12, 2011

First Posted Date

Dec 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2017

Last Update Posted Date

Feb 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is conducted in Asia. The aim of this study is to investigate the safety and efficacy of NovoLet® human insulin delivery system in an outpatient setting.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,981Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NovoLet® device			Drug: biphasic human insulin Drug: isophane human insulin Drug: human soluble insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biphasic human insulin	Drug	NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator	NovoLet® device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in body weight

Secondary Outcomes

Measure	Description	Time Frame
Fasting blood glucose (FBG)
2 hours postprandial blood glucose (2-hr PPBG)
HbA1c (glycosylated haemoglobin)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetes mellitus
Type 2 diabetes mellitus
Other types of diabetes mellitus (gestational, drug induced [thiazide] or metabolic syndrome-related)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with type 1 or type 2 diabetes mellitus or other types of diabetes mellitus (gestational, drug induced or metabolic syndrome-related) who are prescribed NovoLet® human insulin in the course of their diabetes mellitus management can be enrolled in the study

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1457)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Jakarta		12520	Indonesia

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C575870	biphasic human insulin 30
D007336	Insulin, Isophane

Ancestor Terms

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided