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Monitoring the efficacy and safety of lantus in t2 patients failing glycemic control with premix or NPH with OAD or short acting insulin

Monitoring the efficacy and safety of lantus in t2 patients failing glycemic control with premix or NPH with OAD or short acting insulin

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012110411356N1
Enrollment
230
Registered
2012-11-18
Start date
2011-12-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes.

Interventions

glargyn(lantus) The investigator will determine the dosage of insulin glargine according to his needs & based on his other concomitant treatments. The insulin dosage of patients will be up titrated
glargyn(lantus) The investigator will determine the dosage of insulin glargine according to his needs & based on his other concomitant treatments. The insulin dosage of patients will be up titrat

Sponsors

Sanofi Aventis
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 79 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: suffering from diabetes Mellitus type 2; agebetween 19 to 79 years ; patients who previously failed to achieve a glycemic control (HbA1c = 7 %; ADA, EASD.) under premixesi nsulin BD or NPH with OAD or short acting insulins and patients must sign the informed consent. Exclusion criteria: patients with severe renal failure and haemodialysis; patients with sever hepatic failure, pregnancy or breast feeding; mental disorders; hypersensitivity to basal insulin and inability to perform SMBG.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
HbA1c level each visit. Timepoint: 24 weeks. Method of measurement: choromotography.

Secondary

MeasureTime frame
Proportion of patients reaching the glycemic control. Timepoint: 24 weeks. Method of measurement: choromatography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Mir

Sanofi Aventis

Elham.Mir@iran.sanofi-aventis.com+98 21 8864 9710

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026