A Phase 1/2 interventional study of Insulin Isophane Human, NPH, Pre-emptive Algorithm and Triamcinolone Acetonide Knee Injection in Diabetes Mellitus, Type 2, Hyperglycemia Due to Type 2 Diabetes Mellitus and Osteoarthritis, Knee, sponsored by Shifa International Hospital. Active, not recruiting at 1 site in Pakistan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Shifa International Hospital · Phase 1/2, Interventional, and Treatment
Steroid injections used to treat painful joints can temporarily increase glucose levels in people with type 2 diabetes. This study will test whether a short course of pre-emptive neutral protamine Hagedorn, NPH, insulin can reduce high glucose after a standard corticosteroid injection into the knee.
Adults with type 2 diabetes who are scheduled to receive one intra-articular injection of triamcinolone acetonide 40 mg for knee osteoarthritis will be randomly assigned to one of two groups. The experimental group will receive a prespecified NPH insulin regimen beginning immediately after the injection and continuing for three doses. The comparison group will continue usual reactive diabetes management without pre-emptive NPH insulin.
Both groups will use blinded continuous glucose monitoring and scheduled capillary glucose testing. The main outcome is the percentage of continuous glucose monitoring time above 180 mg/dL during the first 72 hours after the corticosteroid injection. Hypoglycaemia, rescue treatment, healthcare contacts, treatment burden, acceptability and adverse events will also be assessed.
Intra-articular corticosteroid injections can produce clinically important but transient hyperglycaemia in people with type 2 diabetes. Published studies have largely characterised this glucose response rather than testing a standardised strategy to prevent it.
PREVENT-SIH is a phase 2, randomised, parallel-group trial in adults with type 2 diabetes managed without insulin or insulin secretagogues. All participants will receive a clinically indicated, standardised intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg into one index knee for symptomatic knee osteoarthritis.
Participants will be randomly assigned 1:1 to a pre-emptive NPH insulin pathway or usual reactive diabetes management. The pre-emptive pathway comprises three weight-based NPH doses starting immediately after the corticosteroid injection, with prespecified glucose-based dose modification, withholding and discontinuation rules. Both groups will continue stable background diabetes medication and will receive identical blinded continuous glucose monitoring, capillary glucose monitoring, safety instructions, scheduled contacts and rescue thresholds.
Continuous glucose monitoring data will be collected for a 72-hour baseline period and for at least 96 hours after injection. The primary analysis will compare the percentage of valid readings above 180 mg/dL during the first 72 hours after injection, adjusted for baseline continuous glucose monitoring time above 180 mg/dL, site and HbA1c stratum. Rescue treatment and other post-randomisation diabetes treatment changes will be retained in the primary treatment-policy analysis.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 125 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Shifa International Hospital is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive three subcutaneous doses of human NPH insulin beginning within 30 minutes after intra-articular triamcinolone acetonide injection and repeated approximately 24 and 48 hours later. The initial dose is 0.10 units/kg, maximum 16 units. Subsequent doses are modified according to prespecified capillary-glucose and hypoglycaemia criteria. Participants will continue stable background diabetes medication and receive blinded continuous glucose monitoring, scheduled capillary glucose testing, safety contacts and the common rescue pathway.
Drug: Insulin Isophane Human, NPH, Pre-emptive Algorithm
Participants will continue stable background diabetes medication without pre-emptive NPH insulin. They will receive blinded continuous glucose monitoring, the same scheduled capillary glucose testing, safety instructions, study contacts and common rescue pathway as the experimental group. Additional non-emergency medication changes may be made by the treating diabetes clinician when clinically necessary and will be documented.
Drug: Triamcinolone Acetonide Knee Injection
Human NPH insulin U-100 will be administered subcutaneously within 30 minutes after the knee injection at 0.10 units/kg actual body weight, rounded to the nearest whole unit, maximum 16 units. Doses are repeated approximately 24 and 48 hours later. For doses 2 and 3, predose glucose below 90 mg/dL requires withholding; 90 to 109 mg/dL requires 50% of the initial dose; 110 to 180 mg/dL requires 100%; 181 to 250 mg/dL requires 120%; and above 250 mg/dL requires 120%, maximum 20 units, plus clinician contact. Any glucose below 54 mg/dL or level 3 hypoglycaemia permanently discontinues study NPH.
Also known as: Human NPH Insulin, Neutral Protamine Hagedorn Insulin
A single 1 mL intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg/mL, total dose 40 mg, will be administered into one index knee using a standardised landmark-guided procedure. Up to 2 mL lidocaine 1% without epinephrine may be used for skin and subcutaneous anaesthesia but will not be mixed with or injected into the joint. No repeat or additional injected corticosteroid is permitted through day 7.
Also known as: Triamcinolone Acetonide Crystalline Suspension
Percentage of Continuous Glucose Monitoring Time Above 180 mg/dL During the First 72 Hours After Corticosteroid Injection
The numerator is the number of valid continuous glucose monitoring readings above 180 mg/dL from the recorded completion time of the intra-articular injection through exactly 72 hours. The denominator is the total number of valid readings during that window. The result is expressed as a percentage. A directly observed outcome requires at least 80% of expected readings and no uninterrupted data gap longer than 6 hours. Participants not meeting this requirement have a missing primary outcome for statistical handling; missing readings are not counted as being within or above range.
Time frame: From completion of the intra-articular corticosteroid injection through 72 hours after injection
Percentage of Continuous Glucose Monitoring Time Above 250 mg/dL
Number of valid continuous glucose monitoring readings above 250 mg/dL divided by all valid readings, multiplied by 100. The primary-outcome valid-data requirements apply.
Time frame: From completion of the injection through 72 hours after injection
Continuous Glucose Monitoring Area Under the Curve Above 180 mg/dL
Incremental area above 180 mg/dL calculated using the trapezoidal rule across adjacent valid readings separated by no more than 30 minutes. The observed mean excess above 180 mg/dL is standardised to a 72-hour period and reported in mg/dL-hours.
Time frame: From completion of the injection through 72 hours after injection
Mean Sensor Glucose
Arithmetic mean of all valid continuous glucose monitoring readings during the assessment window, reported in mg/dL.
Time frame: From completion of the injection through 72 hours after injection
Peak Sensor Glucose
Highest valid continuous glucose monitoring glucose value during the assessment window, reported in mg/dL.
Time frame: From completion of the injection through 72 hours after injection
Time to Peak Sensor Glucose
Elapsed time in hours from completion of the injection to the first occurrence of the participant's peak valid sensor glucose.
Time frame: From completion of the injection through 72 hours after injection
Percentage of Continuous Glucose Monitoring Time in Range, 70 to 180 mg/dL
Number of valid continuous glucose monitoring readings from 70 through 180 mg/dL divided by all valid readings, multiplied by 100.
Time frame: From completion of the injection through 72 hours after injection
Percentage of Continuous Glucose Monitoring Time Below 70 mg/dL
Number of valid continuous glucose monitoring readings below 70 mg/dL divided by all valid readings, multiplied by 100.
Time frame: From completion of the injection through 72 hours after injection
Percentage of Continuous Glucose Monitoring Time Below 54 mg/dL
Number of valid continuous glucose monitoring readings below 54 mg/dL divided by all valid readings, multiplied by 100.
Time frame: From completion of the injection through 72 hours after injection
Participants With Clinically Significant Hypoglycaemia
Number and percentage of participants with capillary glucose below 54 mg/dL, continuous glucose monitoring glucose below 54 mg/dL lasting at least 15 consecutive minutes, or level 3 hypoglycaemia requiring third-party assistance.
Time frame: From completion of the injection through day 7
Participants Requiring Rescue Glucose-Lowering Treatment
Number and percentage of participants receiving protocol rescue insulin or any additional glucose-lowering medication initiated for post-injection hyperglycaemia.
Time frame: From completion of the injection through 72 hours after injection
Number of Unscheduled Diabetes-Related Clinical Contacts or Healthcare Encounters
Count per participant of unscheduled telephone calls, electronic contacts, clinic visits, urgent-care visits or emergency-department encounters primarily related to glucose management.
Time frame: From completion of the injection through day 7
Participant-Reported Treatment Burden Score
Study-specific numerical rating from 0 to 10, where 0 means no treatment burden and 10 means extreme treatment burden.
Time frame: Day 4
Participant-Reported Treatment Acceptability
Single study-specific five-category rating: very unacceptable, unacceptable, neither unacceptable nor acceptable, acceptable, or very acceptable.
Time frame: Day 4
Participants With Adverse Events
Number and percentage of participants experiencing at least one adverse event after the study injection, regardless of relationship.
Time frame: From completion of the injection through day 7
Participants With Serious Adverse Events
Number and percentage of participants experiencing at least one serious adverse event after the study injection.
Time frame: From completion of the injection through day 7
Plan to share: Yes — Deidentified individual participant data underlying the principal published results may be made available together with a data dictionary, study protocol, statistical analysis plan and analytic code. Data sharing will be subject to applicable ethics approval, participant consent, institutional policy and protection against participant reidentification. Data that cannot be adequately deidentified will not be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Beginning 12 months after publication of the primary results and remaining available for 5 years.
Access criteria: Requests will be considered from qualified researchers who submit a methodologically sound proposal with clearly specified objectives, variables and analysis methods. Access will require approval by the sponsor or a designated data-access committee, execution of a data-use agreement, agreement not to attempt reidentification and compliance with any ethics or institutional requirements. Data will be provided through an approved controlled-access repository or secure transfer mechanism.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jan 2027, 4 months after the start.
Of 41 phase 1/2 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 71. This study's planned 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin, Isophane
Shifa International Hospital